Responsibilities:

• Responsible for representing QA on cross-functional teams and executing Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on market.
• Responsible for assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide.
• Products include medical devices and combination products, such as infusion pumps, enteral and sub-cutaneous tubing, Pre-filled Syringes, Autoinjectors, Eyecare Products, Aesthetics Devices, etc.
• Primary driver for the quality and compliance aspects of Design transfer and on-market change management.
• Serve as the primary quality lead for design transfer activities to enable product launch, including transfers both within and outside of Client.
• Mentor/lead product team members through the design transfer process providing guidance to assure optimal approach.
• Own change plans to manage on-market design changes, collaborate with cross-functional team for impact assessments, define and execute action plans, and monitor to ensure timely closure.
• Ensure design control documentation (Traceability/Linkages) & design change control requirements are met.
• Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure.
• Assist 3rd party suppliers during change management process, including change management strategies.
• Identify gaps in existing processes as well as the need for new processes. Lead cross-functional teams for solution development and implementation.
• Support the preparation of regulatory inspections and internal audits and represent QA in inspections and audits as SME.
• Participate in the development of global Product Quality Assurance strategy to support device and combination products produced at Client plants as well as contract manufacturing and supplier facilities. Implements agreed strategy.
• Make recommendations for key decisions on product quality, compliance and regulatory conformance issues.
• Establish and maintain relationships and open communication with suppliers, contract manufacturers, Client plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at each site and provide guidance on quality concerns.
• Initiate assignments independently. Actively lead and participate on development and process improvement teams. Anticipate/resolve quality issues and take preventative actions.
• Actively monitor effectiveness of processes and quality of project work, propose and execute quality/process improvements. Write/review policies/processes/procedures and related documents.
• Conduct, lead, or participate in investigations and review boards for Change Plans, CAPAs, NCRs, Observations, etc.

Requirements:

• Bachelor’s degree in science, engineering, or other technical areas; or equivalent job experience required. Advanced degree preferred; ASQ certification preferred (CQA, CQE, SSBB, etc.)
• 8+ years of relevant experience in the medical device industry; at least 5+ years in Quality Assurance experience required.
• Working knowledge of ISO 13485, ISO 14971, 21 CFR 4, 21 CFR 820, EU Regulation 93/42/EEC (MDD) & 2017/745 (MDR).
• Working knowledge of international standards and regulations applicable to medical devices and combination products.
• Experience with medical devices and/or combination products such as infusion pumps, PFS, Autoinjector, or Eyecare Products preferred.
• Ability to apply practical and technical problem solving to quality system and product improvements.
• Excellent interpersonal skills, including ability to work effectively cross-culturally and cross-functionally.
• Proven ability to effectively lead cross-functional teams and to influence where direct reporting line relationships do not exist.
• Capable of developing matrix relationships with key colleagues in other functional areas and divisions; Recognizes other colleagues’ areas of expertise and utilizes them effectively to achieve team objectives.
• Champions high quality deliverables, innovation, and appropriate risk-based decision making; Ability to understand the sensitivities within the Client’s environment.
• Excellent project management and interpersonal skills.
• Adaptable to changes in work environment.
• Ability to work in a fast-paced environment.

• Responsible for representing QA on cross-functional teams and executing Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on market.
• Responsible for assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide.
• Products include medical devices and combination products, such as infusion pumps, enteral and sub-cutaneous tubing, Pre-filled Syringes, Autoinjectors, Eyecare Products, Aesthetics Devices, etc.
• Primary driver for the quality and compliance aspects of Design transfer and on-market change management.
• Serve as the primary quality lead for design transfer activities to enable product launch, including transfers both within and outside of Client.
• Mentor/lead product team members through the design transfer process providing guidance to assure optimal approach.
• Own change plans to manage on-market design changes, collaborate with cross-functional team for impact assessments, define and execute action plans, and monitor to ensure timely closure.
• Ensure design control documentation (Traceability/Linkages) & design change control requirements are met.
• Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure.
• Assist 3rd party suppliers during change management process, including change management strategies.
• Identify gaps in existing processes as well as the need for new processes. Lead cross-functional teams for solution development and implementation.
• Support the preparation of regulatory inspections and internal audits and represent QA in inspections and audits as SME.
• Participate in the development of global Product Quality Assurance strategy to support device and combination products produced at Client plants as well as contract manufacturing and supplier facilities. Implements agreed strategy.
• Make recommendations for key decisions on product quality, compliance and regulatory conformance issues.
• Establish and maintain relationships and open communication with suppliers, contract manufacturers, Client plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at each site and provide guidance on quality concerns.
• Initiate assignments independently. Actively lead and participate on development and process improvement teams. Anticipate/resolve quality issues and take preventative actions.
• Actively monitor effectiveness of processes and quality of project work, propose and execute quality/process improvements. Write/review policies/processes/procedures and related documents.
• Conduct, lead, or participate in investigations and review boards for Change Plans, CAPAs, NCRs, Observations, etc