Lifecycle Management Manager, Design Quality

Job Description

• Represent QA on cross‑functional teams and execute Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on the 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.
• Primary driver for the quality and compliance aspects of product 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 the organization.
• Lead or support process validation activities (IQ/OQ/PQ/PPQ), including TMV.
• Mentor and lead product team members through the design transfer process, providing guidance to assure an optimal approach.
• Lead or 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 teams for impact assessments, define and execute action plans, and monitor to ensure timely closure.
• Ensure design control documentation (traceability/linkages) and design change control requirements are met.
• Identify gaps and improvement opportunities within the Design History File and Risk Management, and track to closure.
• Assist 3rd‑party suppliers during the change management process, including change management strategies.
• Identify gaps in existing processes and the need for new processes.
• Lead cross‑functional teams for solution development and implementation.
• Support the preparation of regulatory inspections and internal audits; represent QA in inspections and audits as a subject matter expert.
• Participate 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.
• Implement agreed strategy and make recommendations for key decisions on product quality, compliance, and regulatory conformance issues.
• Establish and maintain relationships and open communication with suppliers, contract manufacturers, plants, affiliates, and other functional groups to maintain roles and responsibilities, identify potential projects and issues, understand the quality, compliance, and resource needs at each site, and provide guidance on quality concerns.
• Initiate assignments independently.
• Actively lead and participate in development and process improvement teams.
• Anticipate and resolve quality issues, taking preventative actions.
• Actively monitor effectiveness of processes and quality of project work; propose and execute quality/process improvements.
• Write and review policies, processes, procedures, and related documents.
• Conduct, lead, or participate in investigations and review boards for change plans, CAPAs, NCRs, observations, etc.

• 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.
• 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 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 the ability to work effectively cross‑culturally and cross‑functionally.
• Proven ability to effectively lead cross‑functional teams and influence where direct reporting line relationships do not exist.
• Capability to develop matrix relationships with key colleagues in other functional areas and divisions; recognition of other colleagues’ areas of expertise and effective utilization to achieve team…