General Summary
The Operational Area Quality Senior Manager provides quality leadership for assembly manufacturing operations supporting medical device and combination products. The role is responsible for quality oversight of manufacturing operations, product disposition, batch record review, deviations, investigations, CAPAs, change controls, supplier quality, and regulatory compliance while partnering with manufacturing, engineering, supply chain, and external manufacturing partners. The position also supports design quality activities to ensure manufacturing changes remain aligned with design control and risk management requirements throughout the product lifecycle.
Key Duties and Responsibilities
- Lead Quality Assurance support for assembly manufacturing operations of medical device and combination products, ensuring compliance with GMP, regulatory requirements, and internal quality systems.
- Provide quality oversight for product disposition activities, including review and approval of manufacturing documentation to support timely release of clinical and commercial product.
- Review and approve Manufacturing Batch Records (MBRs), Electronic Batch Records (EBRs), Device History Records (DHRs), and associated manufacturing documentation.
- Lead and approve manufacturing deviations, investigations, nonconforming material reports (NCMRs), CAPAs, change controls, and effectiveness checks.
- Conduct and lead root cause investigations using structured problem-solving methodologies and ensure implementation of effective corrective and preventive actions.
- Support manufacturing operations by providing real-time quality oversight for assembly processes, equipment issues, process improvements, and manufacturing investigations.
- Partner with Contract Manufacturing Organizations (CMOs) to ensure compliance with Quality Agreements, disposition requirements, manufacturing investigations, and continuous improvement initiatives.
- Support manufacturing process validation, equipment qualification, technology transfers, and process improvements to ensure products remain in a validated state.
- Lead supplier quality activities including supplier investigations, supplier change assessments, supplier qualification, and quality issue resolution.
- Support regulatory inspections, customer audits, supplier audits, and internal audits while ensuring timely responses and closure of observations.
- Support complaint investigations and product quality assessments as required.
- Support Design Quality activities by reviewing design changes, participating in design reviews, supporting Design History File maintenance, and ensuring manufacturing changes are appropriately evaluated through design controls and risk management.
- Provide input into risk management activities, including DFMEA, PFMEA, hazard analyses, and Risk Management Files, to ensure manufacturing risks are appropriately evaluated throughout the product lifecycle.
- Promote continuous improvement initiatives to enhance manufacturing quality, compliance, operational efficiency, and product reliability.
Knowledge and Skills
- Strong experience supporting assembly manufacturing operations for medical devices and combination products.
- Demonstrated experience reviewing and approving MBRs, EBRs, DHRs, product disposition, manufacturing investigations, CAPAs, deviations, change controls, and nonconforming material records.
- Strong knowledge of autoinjector and drug-device combination products, including assembly processes, manufacturing operations, supplier management, and product lifecycle support.
- Demonstrated knowledge of GMP, 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and applicable combination product regulations.
- Experience supporting process validation, equipment qualification, technology transfers, and manufacturing readiness.
- Experience working with Contract Manufacturing Organizations (CMOs) and external suppliers.
- Working knowledge of Design Controls and Risk Management to support manufacturing quality activities and lifecycle changes.
- Strong technical problem-solving, investigation, and root cause analysis skills.
- Excellent leadership, communication, and cross-functional collaboration skills.
- Experience with statistical analysis tools, Minitab, and quality engineering methodologies preferred.
Education and Experience
- Bachelor’s degree in Engineering, Life Sciences, Quality, Manufacturing, or a related technical discipline is required. Advanced degree preferred.
- Typically requires 10+ years of Quality Assurance, Quality Engineering, Manufacturing Quality, or Operations Quality experience within the medical device, biotechnology, pharmaceutical, or combination product industry.
- Minimum of 5 years supporting GMP manufacturing operations, including assembly manufacturing, product disposition, deviation management, investigations, CAPA, change control, and batch record review.
- Demonstrated experience supporting autoinjector, prefilled syringe, or other drug-device combination products from clinical through commercial manufacturing.
- Experience leading cross-functional quality initiatives and partnering with Contract Manufacturing Organizations (CMOs) and suppliers.
- Prior people leadership or demonstrated technical leadership of complex quality programs is preferred
