Design Quality Manager

Job Description:

• Manager, Design Quality - Lifecycle Management 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 while 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, Aesthetic Devices, etc.

Roles & Responsibilities:

• Primary driver for the quality and compliance aspects of product transfer and on-market change management.
• Serves as the primary quality lead for design transfer activities to enable product launch, including transfers both within and outside of organization.
• Lead/support process validation activities (IQ/OQ/PQ/PPQ), including TMV.
• Mentor/lead product team members through the design transfer process providing guidance to assure optimal approach.
• Lead/support lifecycle design change projects following Design Control and Change Control principles.
• 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.
• Participates in the development of global Product Quality Assurance strategy to support device and combination products produced at plants as well as contract manufacturing and supplier facilities. Implements agreed strategy.
• Makes recommendations for key decisions on product quality, compliance and regulatory conformance issues.
• Establishes and maintains relationships and open communication with suppliers, contract manufacturers, 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.

Education & Experience:

• Bachelor's degree in engineering, science, or other technical areas; Advanced degree preferred; ASQ certification preferred (CQA, CQE, SSBB, etc.).
• 8+ years of relevant experience in the medical device or combination product industry; 5+ years of Quality Assurance experience required.
• Design Control Principles.
• Change Control Principles.
• Working knowledge of Medical Devices and Combination Products (MDCP), such as Infusion Pumps, On Body Injectors, PFS.
• FDA/EU regulations on MDCP.
• Working knowledge of ISO 13485, ISO 14971, 21 CFR Part 4, 21 CFR Part 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 infusion pumps, PFS, Autoinjector, or On Body Injector 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 environment.