Karriere

Karriere

BVI ist immer auf der Suche nach engagierten, innovativen und talentierten Fachleuten, die daran interessiert sind, ihre Laufbahn in der Augenheilkunde zu verfolgen. Wir suchen Menschen, die ständig hinzulernen, zusammenarbeiten und die Augengesundheit auf der ganzen Welt fördern möchten.  Unsere geschätzten BVI-Mitarbeiter genießen ein komplettes Leistungspaket und ein wettbewerbsfähiges Gehalt. Die Leistungen werden zum Zeitpunkt des Stellenangebots individuell besprochen.

BVI unterstützt als Arbeitgeber die Chancengleichheit / positive Diskriminierung (Link). Alle qualifizierten Bewerber erhalten eine Mitarbeitervergütung ungeachtet ethnischer Herkunft, Hautfarbe, Religion, Geschlecht, nationaler Herkunft, Behinderung oder eines geschützten Veteranenstatus.

Bewerbung für Positionen in Nordamerika

Bewerbung für internationale Positionen

All potential candidates interested in an International Position are asked to submit a cover letter and C.V. to internationalHR@bvimedical.com for international consideration.

Sr. Salesforce Developer

Overview

A Heritage of Precision, Innovation and Quality

Beaver-Visitec International is focused on developing and manufacturing new, innovative and reliable products for a variety of ophthalmic and specialty microsurgical procedures. Our products are distributed worldwide by sales and marketing professionals recognized throughout the industry for their clinical expertise and outstanding customer service.

Beaver-Visitec International is currently seeking a Sr. Salesforce Developer As a valued employee of Beaver-Visitec, you will enjoy a total benefits package including competitive salary, medical/dental/vision/life insurance, short- and long-term disability, fitness reimbursement, 401k, and more.

The Sr. Salesforce Developer Manages support, design and development initiatives for the rollout of Salesforce, Salesforce CPQ, HRIS and LMS systems.Identify areas/potential projects where process redesign/improvement can significantly impact efficiency, quality, profitability, competitive position and customer experience; work closely with Business Partners to ensure that process improvement projects support the strategic priorities of the organization; teach process improvement classes and coach process improvement practitioners across the company. Seeks out and champions new business and technology initiatives with company stakeholders.

Responsibilities

Provides clear leadership and support of Salesforce, HRIS and LMS deployed systems consistent with the objectives of fulfilling BVI’s’s vision, mission, policies and procedures. Direct efforts toward high-value results. Set goals and objectives. Ensure that 3rd party development organizations comply with BVI standards and procedures; Responsible for the design,development and maintenance of Salesforce, Salesforce CPQ, Sage HRIS and LMS systems; Work closely with Business and IT staff in BVI Regional and Global IT organizations. Coordinate Plant and Business activities, implement Regional and Global initiatives for globally deployed Business Systems; Ensure that BVI Waltham globally deployed Systems are in compliance with BVI corporate directives, FDA regulations, and ISO standards; Responsible for creating and managing project budget. Will create capital requests as needed.

Qualifications

3+ years of Salesforce development experience with Apex, Visualforce, triggers, batch Apex and Salesforce APIs 3+ years of experience configuring Salesforce using workflows, validation rules, enterprise territory management 2.0, roles & profiles, reports and dashboards; Understanding of the architecture, capabilities and constraints of Salesforce applications; Database experience writing queries in SQL/SOQ; Working with Data Loader or various ETL tools a plus; Experience integrating Salesforce with other applications using SOAP, REST, BULK APIs; Certified Salesforce Advanced Administrator or equivalent experience Certified Salesforce Platform Developer or equivalent experience; Certified Salesforce Platform App Builder or equivalent experience; Proficiency in HTML, XML, Flex, JavaScript, ASP, SQL, Java or C++, SOAP-based web services; BS in CS or related field and Masters preferred

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

Import and Export Compliance Analyst

Overview

A Heritage of Precision, Innovation and Quality

Beaver-Visitec International is focused on developing and manufacturing new, innovative and reliable products for a variety of ophthalmic and specialty microsurgical procedures. Our products are distributed worldwide by sales and marketing professionals recognized throughout the industry for their clinical expertise and outstanding customer service.

Beaver-Visitec International is currently seeking a Import and Export Compliance Analyst. As a valued employee of Beaver-Visitec, you will enjoy a total benefits package including competitive salary, medical/dental/vision/life insurance, short- and long-term disability, fitness reimbursement, 401k, and more.

Responsible for ensuring import and export transactions are compliant with both US and International Customs rules and regulations.  The position acts as a liaison among several internal groups to ensure proper adherence to trade control laws and regulations.

Responsibilities

Properly classifies BVI products with the appropriate harmonized tariff code, ECCN and Country of Origin; Verifies and maintains international product data including tariff codes, ECCN and Country of Origin in the classification database; Provide shipment clearance instructions to BVI Customs Brokers, ensuring full compliance with CBP and other government agencies; Audit import entries for global BVI business units to ensure adherence to clearance instructions; Reviews and approves shipping documentation from overseas suppliers to ensure accuracy of documentation for a timely and efficient customs clearance process; Responsible for record retention of import/export documents in accordance with government regulations and Company policy; Assists with preparation for participation in government programs, such as CTPAT and ISA , in coordination with the Director, Global Trade Compliance; Participates in the creation of Import and Export Compliance procedures and work instructions; Prepares export documentation to ensure compliance with US Government laws and regulations and files Electronic Export Information in ACE; Prepares and maintains documentation in support of qualification of products under preferential trade programs; Knowledge of US trade laws and regulations such as the Export Administration Regulations (EAR), Office of Foreign Assets Control (OFAC) Regulations, US Customs and Border Protection Regulations, and other regulatory requirements; Supports investigations, internal and external audits, and other compliance initiatives as required by the business; Performs other trade management and compliance related duties as assigned.

Qualifications

Three to five years in Import/Export Compliance roles processing import and export transactions; Strong understanding of US Customs and Other Government Agency regulations, including FDA, is essential; Thorough knowledge of the Harmonized Tariff Schedule (HTS) and expertise in classification of a diverse range of products; Experience with EAR and OFAC Export compliance programs required; Bachelors degree or equivalent; Sitting for long periods of time; standing; squatting; reaching; computer work (typing), phone usage; filing; lifting up to 20 lbs. unassisted.

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

Customer Service Representative

Overview

A Heritage of Precision, Innovation and Quality

Beaver-Visitec International is focused on developing and manufacturing new, innovative and reliable products for a variety of ophthalmic and specialty microsurgical procedures.  Our products are distributed worldwide by sales and marketing professionals recognized throughout the industry for their clinical expertise and outstanding customer service.  We have that “start-up” feel but have several well-established and recognized brands in our portfolio.  We are continuously striving to improve our existing products while creating new, innovative products as technologies and market needs change.

Beaver-Visitec International is currently seeking a Customer Service Representative As a valued employee of Beaver-Visitec, you will enjoy a total benefits package including competitive salary, medical/dental/vision/life insurance, short- and long-term disability, fitness reimbursement, 401k, and more.

Responsibilities

The Customer Service Representative (CSR) will answer incoming calls from the customer service queue in a timely manner and will provide the highest level of customer satisfaction possible to both internal and external customers.  The CSR will be capable of processing RMAs in an expeditious and accurate manner, and will process customer orders (phone, fax and mail), special orders, drop ship orders and customer changes according to established department policies and procedures in a timely and accurate fashion.  The CSR will use an ERP system to provide prompt and efficient information to customers, call customers when necessary, and guide customers to other internal resources as necessary.  Document and resolve customer problems, complaints and issues promptly in a positive, win-win manner that will retain and promote customer loyalty in accordance with company processes.  Works effectively with others in a team environment to accomplish organizational goals and to identify and resolve problems.  The CSR will take initiative and personal ownership for meeting established individual and team metrics, and will meet or exceed monitoring standards on phones.

Qualifications

Associate’s degree and 2+ years of proven customer service experience or High School Diploma with 5-7 years of experience.  Bachelor’s degree and related (medical device) experience highly preferred.  Knowledge of customer service standards, procedures, principles and practices is desirable.  Demonstrated commitment to provide superior customer service must be evident.  Excellent PC/system skills, and be computer literate with the ability to learn software programs like Microsoft Office (Excel, Word, PowerPoint), Outlook and other databases (ERP Systems, ACT).  The CSR should possess strong data entry skills including accuracy, efficiency, and attention to detail, plus effective communication skills, both verbal and written, and comfortable interacting with customers and internal partners in a professional manner via the phone.  Previous knowledge of the Ophthalmic or Medical Device industry is a plus.

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

Sales Support Representative

Overview

A Heritage of Precision, Innovation and Quality

Beaver-Visitec International is focused on developing and manufacturing new, innovative and reliable products for a variety of ophthalmic and specialty microsurgical procedures. Our products are distributed worldwide by sales and marketing professionals recognized throughout the industry for their clinical expertise and outstanding customer service.

Beaver-Visitec International is currently seeking a Sales Support Representative As a valued employee of Beaver-Visitec, you will enjoy a total benefits package including competitive salary, medical/dental/vision/life insurance, short- and long-term disability, fitness reimbursement, 401k, and more.

The Sales Support Representative is responsible for providing the highest level of support and satisfaction to BVI US Sales team and customers in support of sales growth objectives and delivering world class service experience for customers. Assists sales staff with all phases of CustomEyes quoting, planning and order processing. The Sales Support Representative will serve as SME for CustomEyes products and process, IFS and Salesforce and will provide ongoing support to team members by entering all customer touchpoints in CRM, assisting with pipeline management, identifying product category sales opportunities and communicating information impacting customers to sales.

Responsibilities

Provide the highest level of support to BVI US Sales Team; Point person for sales team and key customers for calls, e-mails, orders, CustomEyes support, pricing questions and problem resolution; Monitors Pipeline to drive sales and updates all activity in CRM; Participates in Sales Campaigns as directed; Support all aspects of our custom kit business (CustomEyes and Readypak); Process quotes for accuracy and approval; Communicates CustomEyes timeline milestones to Sales; Assists Sales by identifying product category opportunities; Documents customer touchpoints in CRM, updates contact data in IFS and CRM, schedule and follow up on open tasks.

Qualifications

2+ years of proven customer service experience (within BVI is preferred). Meets all skills required from general CS Rep requirements. Proficiency with IFS or other ERP System, Strong PC skills: Outlook, Office Suite.Ability to build rapport & foster strong relationships, able to manage time effectively, strong problem solving skills; Experience with Salesforce.com preferred; Associate's degree or 4+ years of related experience; Must be able to read/write in English. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit and reach with hands and arms. Computer work; lift up to 20 lbs unassisted. Some travel may be required (Sales Meetings, Customer Site Visits, Tradeshows).

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

Principal Regulatory Affairs & Medical Affairs Specialist

Overview

A Heritage of Precision, Innovation and Quality

Beaver-Visitec International is focused on developing and manufacturing new, innovative and reliable products for a variety of ophthalmic and specialty microsurgical procedures. Our products are distributed worldwide by sales and marketing professionals recognized throughout the industry for their clinical expertise and outstanding customer service.

Beaver-Visitec International is currently seeking a Principal Regulatory Affairs & Medical Affairs Specialist as a valued employee of Beaver-Visitec, you will enjoy a total benefits package including competitive salary, medical/dental/vision/life insurance, short- and long-term disability, fitness reimbursement, 401k, and more.

 The Principal RA & Medical Affairs Specialist basic Functions:

Regulatory and clinical supports new product development for global product development release by contributing to the development and updating of regulatory strategy based upon regulatory changes. Supports the product lifecycle (e.g., Complaints, HHAs, PMS, PMCF, PSUR) through obsolescence by assessing regulatory changes made to the products and processes during post launch to determine regulatory impact of global changes to the current clearance/approvals or authorizations.

Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals for FDA, Europe (MDD and EU MDR), and other global, regional or state regulatory bodies for market authorization and maintenance of registrations and license.

Medical affairs for business based on clinical experience and/or product knowledge. Interface with KOLs and other appropriate medical experts in the field of Ophthalmology, ENT or other (MDs, surgeons) to support clinical experience and validation of clinical decisions related to patient or user hazards and/or benefits/risks. Viewed as divisional resource.

Responsibilities

Works with minimal supervision and instruction of more experienced staff; Takes a technical leadership role on one or more projects of significance e.g. global technical submissions; Reports observations/problems clearly and concisely, recognizing and highlighting specific deviations; Demonstrates developing strategic and tactical technical leadership skills; Applies comprehensive strategic and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures; Demonstrates strong technical and project management skills, and is actively engaged in regulatory strategy, operations and activities spanning the product lifecycle, business/organizational activities; Demonstrate skills and knowledge in areas such as: strategy development, risk assessment and benefit/risk management; monitoring and communicating change in the regulatory environment as well as global communication; vendor development and management of international regulatory consultant and authorities; and influencing the regulatory environment; Plans, conducts and supervises assignments, reviewing progress and evaluating results; Recommends changes in procedures; Operates with substantial latitude for independent action or decision, and reviews progress with management.

Tasks may include:

Evaluating regulatory risks of corporate policies; Developing new global regulatory policies, procedures and SOPs and training key personnel e.g. US FDA, EU MDR or the rest-of-the-world (ROW) based on skill set and experience; Assisting in the development and advancement of policy and procedures for regulatory affairs and compliance to establish a compliant culture within the organization; Utilizing technical regulatory skills to propose strategies on complex issues; Monitoring emerging issues and identify solutions; Monitoring trade association positions for impact on company products; Providing regulatory input to product lifecycle planning; Anticipating regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams; Evaluating the effect of regulatory requirements on product positions; Assisting in the development of global, regional and multi-county regulatory strategy and updating strategy based upon regulatory changes; Determining submission and approval/clearance requirements; Monitoring regulatory outcomes of initial product concepts and provide input to senior regulatory management; Assisting in Regulatory due diligence and business integration(s); Technical writing, reviews and feedback e.g. Technical Submissions and Clinical Evaluations; Interviewing, and mentoring junior regulatory professionals; Successfully operates within Program Management principles.

Additional tasks may include:

Providing strategic input and technical guidance on regulatory requirements to development teams; Evaluating risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions; Evaluating proposed preclinical, clinical and manufacturing changes for regulatory filing strategies; Managing and executing preapproval compliance activities; Assessing the acceptability of quality, preclinical and clinical documentation for submission filing; Negotiating and interacting with regulatory authorities during the development and review process to ensure submission approval/clearance; Identifying issues early in the submission preparation process that could impact product launch; Monitoring the impact of changing regulations, on submission strategies and update internal stakeholders, Prepare regulatory submissions; Proposing risk-based decisions on special access approval with appropriate regulatory agencies to pursue approvals based on patient needs and risk assessment; Maintaining annual licenses, registrations, listings and patent information; Ensuring compliance with product post-marketing approval requirements; Reviewing and approving labeling, advertising, and promotion materials to ensure compliance with regulations and company; Reviewing publicly disseminated information to minimize regulatory exposure, review product claims and preserve confidentiality of applicable product information; Reviewing and approving required reports, supplemental submissions and other post-marketing commitments to update and maintain product approvals and registrations; Providing regulatory input for and appropriate follow-up to inspections and audits; Developing, implementing and managing appropriate SOPs and systems to track and manage product-associated events; Submitting and reviewing change controls to determine the level of change and consequent submission requirements.

Qualifications

Ability to understand and explain detailed regulatory compliance programs and/or issues; Ability to comply with constantly changing regulatory procedures and prioritize work effectively; Ability to analyze and resolve non-routine regulatory issues using independent judgment; Must be able to observe and correct minute inconsistencies (e.g. in the written word, form usage, etc.); Ability to communicate and network with regulatory personnel to obtain relevant information; Must be able to work with cross functional teams; Ability to plan and conduct meetings; Ability to negotiate internally and externally with regulatory authorities (e.g FDA, Competent Authorities, Notified Bodies); Excellent analytical and writing skills; Effective interpersonal communication skills; Effective organizational skills; Advance PC skills; Previous experience in legal, technical or a regulated environment; 9 or more years of regulatory experience in the medical device industry; Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently to lift, carry, etc. Generally involves sitting most of the time; Must be able to review printed material; Must be able to communicate with others telephonically; A. or B.S. in Science, Legal, Regulatory or Engineering, or equivalent; RAC certification or Advanced Degree (Masters in Regulatory Affairs) required; Certified ophthalmic assistant, technician or technologist; or surgical technologist a plus; Must be able to use common office equipment (e.g. PC, telephone).

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

Senior Product Development Engineer

Overview

A Heritage of Precision, Innovation and Quality

Beaver-Visitec International is focused on developing and manufacturing new, innovative and reliable products for a variety of ophthalmic and specialty microsurgical procedures. Our products are distributed worldwide by sales and marketing professionals recognized throughout the industry for their clinical expertise and outstanding customer service.

Beaver Visitec International is currently seeking a Senior Product Development Engineer as a valued employee of Beaver-Visitec, you will enjoy a total benefits package including competitive salary, medical/dental/vision/life insurance, short- and long-term disability, fitness reimbursement, 401k, and more.

Responsible for leading and managing high impact R&D initiatives including new opportunity identification, technology development, product development and line extensions in support of business objectives.

Responsibilities

Interact with other departments such as management, research, engineering, marketing and new business development to identify core technical competencies that fit with current business focus and potential new markets; Apply sound technical and business principles to investigate new product development opportunities; Support Sales and Marketing in defining market and customer needs and in developing a business plan in target markets; Specify design requirements for current and future products by working closely with sales, marketing and healthcare providers; Provide technical and project leadership over complex design, development and research projects; Effectively provide guidance to project teams in development of products and technologies from concept to commercialization while adhering to medical device design controls/regulatory requirements; Define product specifications, design inputs, product design, verification testing and supporting design validation studies; Perform engineering analyses to support new and existing designs; Fabricate prototypes with assistance from junior staff, technical support team and internal and external suppliers; Work with internal and external manufacturing partners to ensure producible designs (DFM); Contribute to company Intellectual Property Portfolio; Hold self and team members accountable to meet commitments; Ensure budgets and schedules are well planned and followed; Effectively communicate activity status, issues and mitigation plans with key stakeholders.

Qualifications

Minimum of 10 years of experience in product development in the surgical, disposable products or related industries; Experience interfacing and building relationships with Clinicians and KOL’s; Familiar with Concept Engineering (i.e., VOC, observational research, ODI, etc.); Proven track records of developing products from concept to launch; Knowledge of cGMP’s and FDA/CE Mark regulatory requirements; Experience with Design for Six Sigma (DFSS) tools and methodology; Minimum B.S. in Engineering discipline; Sitting and standing  for long periods  of time; bending; squatting; lifting up to 30 lbs; attending trade shows; observing surgery in OR.  Travel up to 20%.

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

Principal Regulatory Affair Specialist

Overview

A Heritage of Precision, Innovation and Quality

Beaver-Visitec International is focused on developing and manufacturing new, innovative and reliable products for a variety of ophthalmic and specialty microsurgical procedures. Our products are distributed worldwide by sales and marketing professionals recognized throughout the industry for their clinical expertise and outstanding customer service.

Beaver-Visitec International is currently seeking a Principal Regulatory Affairs Specialist as a valued employee of Beaver-Visitec, you will enjoy a total benefits package including competitive salary, medical/dental/vision/life insurance, short- and long-term disability, fitness reimbursement, 401k, and more.

Regulatory supports new product development for global product development release by contributing to the development and updating of regulatory strategy based upon regulatory changes. Supports the product lifecycle (e.g., Complaints, HHAs, PMS, PMCF, PSUR) through obsolescence by assessing regulatory changes made to the products and processes during post launch to determine regulatory impact of global changes to the current clearance/approvals or authorizations.

Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals for FDA, Europe (MDD and EU MDR), and other global, regional or state regulatory bodies for market authorization and maintenance of registrations and license.

Responsibilities

Works with minimal supervision and instruction of more experienced staff;Takes a technical leadership role on one or more projects of significance e.g. global technical submissions; Reports observations/problems clearly and concisely, recognizing and highlighting specific deviations; Demonstrates developing strategic and tactical technical leadership skills; Applies comprehensive strategic and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures; Demonstrates strong technical and project management skills, and is actively engaged in regulatory strategy, operations and activities spanning the product lifecycle, business/organizational activities; Demonstrate skills and knowledge in areas such as: strategy development, risk assessment and benefit/risk management; monitoring and communicating change in the regulatory environment as well as global communication; vendor development and management of international regulatory consultant and authorities; and influencing the regulatory environment; Plans, conducts and supervises assignments, reviewing progress and evaluating results; Recommends changes in procedures; Operates with substantial latitude for independent action or decision, and reviews progress with management.

Tasks may include:

Evaluating regulatory risks of corporate policies; Developing new global regulatory policies, procedures and SOPs and training key personnel e.g. US FDA, EU MDR or the rest-of-the-world (ROW) based on skill set and experience; Assisting in the development and advancement of policy and procedures for regulatory affairs and compliance to establish a compliant culture within the organization; Utilizing technical regulatory skills to propose strategies on complex issues; Monitoring emerging issues and identify solutions; Monitoring trade association positions for impact on company products; Providing regulatory input to product lifecycle planning; Anticipating regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams; Evaluating the effect of regulatory requirements on product positions; Assisting in the development of global, regional and multi-county regulatory strategy and updating strategy based upon regulatory changes; Monitoring regulatory outcomes of initial product concepts and provide input to senior regulatory management; Assisting in Regulatory due diligence and business integration(s); Technical writing, reviews and feedback e.g. Technical Submissions and Clinical Evaluations reviews; Interviewing, and mentoring junior regulatory professionals; Successfully operates within Program Management principles.

Additional tasks may include:

Providing strategic input and technical guidance on regulatory requirements to development teams; Evaluating risk of and regulatory solutions to product and clinical safety issues and recommend solutions; Evaluating proposed manufacturing changes for regulatory filing strategies; Managing and executing preapproval compliance activities; Assessing the acceptability of documentation for submission filing; Negotiating and interacting with regulatory authorities during the development and review process to ensure submission approval/clearance; Identifying issues early in the submission preparation process that could impact product launch; Monitoring the impact of changing regulations, on submission strategies and update internal stakeholders, Prepare regulatory submissions; Proposing risk-based decisions on special access approval with appropriate regulatory agencies to pursue approvals based on patient needs and risk assessment; Maintaining annual licenses, registrations, listings and patent information; Ensuring compliance with product post-marketing approval requirements; Reviewing and approving labeling, advertising, and promotion materials to ensure compliance with regulations and company; Reviewing publicly disseminated information to minimize regulatory exposure, review product claims and preserve confidentiality of applicable product information; Reviewing and approving required reports, supplemental submissions and other post-marketing commitments to update and maintain product approvals and registrations; Providing regulatory input for and appropriate follow-up to inspections and audits; Developing, implementing and managing appropriate SOPs and systems to track and manage product-associated events; Submitting and reviewing change controls to determine the level of change and consequent submission requirement.

Qualifications

Excellent analytical and writing skills; Effective interpersonal communication skills; Effective organizational skills; Advance PC skills; Previous experience in legal, technical or a regulated environment; 9 or more years of regulatory experience in the medical device industry; A. or B.S. in Science, Legal, Regulatory or Engineering, or equivalent; RAC certification or Advanced Degree (Masters in Regulatory Affairs) a plus; Certified ophthalmic assistant, technician or technologist; or surgical technologist a plus; Must be able to work with cross functional teams; Ability to plan and conduct meetings; Ability to negotiate internally and externally with regulatory authorities (e.g FDA, Competent Authorities, Notified Bodies); Ability to understand and explain detailed regulatory compliance programs and/or issues; Ability to comply with constantly changing regulatory procedures and prioritize work effectively; Ability to analyze and resolve non-routine regulatory issues using independent judgment; Must be able to observe and correct minute inconsistencies (e.g. in the written word, form usage, etc.); Ability to communicate and network with regulatory personnel to obtain relevant information; Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently to lift, carry, etc. Generally involves sitting most of the time; Must be able to review printed material; Must be able to communicate with others telephonically; Must be able to use common office equipment (e.g. PC, telephone).

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

Senior Design Quality Assurance/ Sustaining Quality Engineer

Overview

A Heritage of Precision, Innovation and Quality

Beaver-Visitec International is focused on developing and manufacturing new, innovative and reliable products for a variety of ophthalmic and specialty microsurgical procedures. Our products are distributed worldwide by sales and marketing professionals recognized throughout the industry for their clinical expertise and outstanding customer service.

Beaver-Visitec International is currently seeking a Senior Design Quality Assurance/ Sustaining Quality Engineer as a valued employee of Beaver-Visitec, you will enjoy a total benefits package including competitive salary, medical/dental/vision/life insurance, short- and long-term disability, fitness reimbursement, 401k, and more.

The Senior Design QA/ Sustaining Quality Engineer will report to the design quality assurance Manager and should be an experienced professional with wide-ranging experience in Design Quality.

Responsibilities

Execute Quality Deliverables: Lead the execution of Quality Deliverables such as Project Design & Development Plan, Field Assessment Plan, and Design & Usability Validation Plans. Lead the execution of the Risk Management deliverables to ensure compliance to ISO 14971 and demonstrates a primary commitment to patient safety. Lead product usability and design validation efforts for new product development and design change projects.  Guides the successful completion of programs and may function in a project leadership role. Design Controls: Providing quality and compliance input to the project team for project decisions and deliverables (e.g. Design & Development Plan, Product Specification, Test Methods, Design Review, Design V&V, Usability Testing, SW Validation, Process Validation, and Labeling) whether internal, co-developed or externally manufactured. Provide quality and regulatory guidance to assure country specific compliance to the laws and regulations of the targeted market for distribution. Champions 100% compliance to Company Policy and SOP’s. Devise and support the implementation of effective quality assurance, process controls, statistical analyses, and metrics that assure products meet or exceed internal quality as well as statutory requirements. Suppliers: Provide product specific supplier and co-development quality assurance expertise during supplier audits, and through approval of supplier PDP and Design Controls deliverables. Measure and oversee the real-time continued quality of internal and external Component and Finished Good Suppliers. May represent the organization as the technical contact on contracts and projects. Interacts with external personnel on technical matters often requiring coordination between organizations. Uses diplomacy and tact to resolve difficult situations. Audit Support: Support internal and external regulatory audits. Product Support: Develops solutions to technical problems which require the regular use of ingenuity and creativity. Analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, specialized techniques and evaluation criteria for obtaining results. Provide quality and compliance input and leads product development and/or post market product sustaining activities, such as design changes, supplier auditing and surveillance, design concessions, product CE marking and safety certification, customer complaint investigations, NCEP’s, CAPA’s, PIR’s and Field Actions. Lead CAPA efforts, and apply sound, systematic problem solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues (e.g., 5 why’s analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies). Quality System Champion: May lead specialized technical project teams which have a broad impact on the company utilizing cross-functional resources. Act as division representative on cross-divisional projects defining the quality system(s). Provides technical leadership to business units. Advise management on potential improvements or enhancement to quality systems and processes in the company. Support development, implementation and training of corporate quality initiatives. Additional Responsibilities. Identifies and implements effective risk management, usability, process and design control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external quality and regulatory requirements. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Assure the development and execution of streamlined business systems, which effectively and efficiently comply with procedural and regulatory requirements and are robust to identify and resolve quality issues.

Qualifications

In depth familiarity with the FDA, ISO, MDD/MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management. Detailed understanding and working knowledge of US and International regulations including 21CFR820, 803, 50, and 11 is required, as well as the Medical Device Directive/ Medical Device Regulation, EN ISO 13485, EN ISO 14971, IEC 60601, and EN 62366. Strong communication and presentation skills. Competent with use of Microsoft Office Suite and Minitab Statistical Analysis software (or equivalent). 5+ years of medical device engineering experience preferred. BS in Mechanical, Electrical, or Biomedical Engineering (or equivalent). Minimum of 5 years of medical device engineering experience

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

Global Distribution Analyst

Overview

A Heritage of Precision, Innovation and Quality

Beaver-Visitec International is focused on developing and manufacturing new, innovative and reliable products for a variety of ophthalmic and specialty microsurgical procedures. Our products are distributed worldwide by sales and marketing professionals recognized throughout the industry for their clinical expertise and outstanding customer service.

Beaver-Visitec International is currently seeking a Global Distribution Analyst as a valued employee of Beaver-Visitec, you will enjoy a total benefits package including competitive salary, medical/dental/vision/life insurance, short- and long-term disability, fitness reimbursement, 401k, and more.

Reporting directly to the Global Distribution Manager, the Global Distribution Analyst will be responsible for the accuracy of finished goods inventory within all BVI distribution centers.  This position will work collaboratively with third-party logistics providers and internal customers to ensure BVI's customer needs are met though exceptional service.

Responsibilities

Ensure inventory alignment between 3PLs and IFS. Eliminate delays within BVI’s control for export and import shipments. Collaborate with internal customer service department in U.S. and UK. Project related activity/support. Accountable for setting own work direction and completing work tasks. Inaccurate decisions or recommendations may cause delays in customer order fufillment and result in the allocation of more resources, diminish finished goods availability, additional shipping costs, and overall customer unsatisfaction. Has some effect on quality, delivery, and cost.

Qualifications

Warehouse and/or 3PL management experience. Associate degree. Sitting for long periods of time; computer work (typing), phone usage; filing; lifting up to 20 lbs. unassisted.  10% travel required. Healthcare experience.

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

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