OverviewThe Associate Director, Quality Medical Device Engineer will lead quality oversight activities for drug-device combination products, including prefilled syringes, autoinjectors, on-body delivery systems, and related medical device constituents. This position will partner closely with Technical Operations, Device Development, Regulatory Affairs, Clinical, Supply Chain, and external manufacturing partners to establish and maintain compliant quality systems and ensure the successful development and commercialization of combination products.
Responsibilities
- Serve as the Quality lead and Subject Matter Expert (SME) for combination product and medical device constituent quality activities.
- Provide strategic oversight of combination product development programs from concept through commercialization.
- Ensure compliance with FDA 21 CFR Part 4, 21 CFR Part 820/Quality Management System Regulation (QMSR), applicable ISO standards, EU MDR requirements, and other relevant global regulations.
- Support implementation and maintenance of a compliant combination product quality system aligned with corporate quality objectives.
- Provide quality oversight for design control activities, including design planning, design inputs/outputs, verification, validation, transfer, and design changes.
- Review and approve design history file (DHF) documentation and associated quality records.
- Participate in design reviews and ensure appropriate risk-based decision making throughout product development.
- Ensure usability engineering and human factors considerations are incorporated into development activities as required.
- Lead and support risk management activities in accordance with ISO 14971.
- Review and approve risk assessments, hazard analyses, FMEAs, and risk management reports.
- Provide quality oversight of medical device suppliers, contract manufacturers, and combination product partners.
- Support supplier qualification, auditing, monitoring, and performance management activities.
- Review and approve supplier quality agreements and technical quality documentation.
- Drive resolution of supplier quality issues through robust investigation and corrective action processes.
Qualifications
- Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, Quality Engineering, or related scientific discipline required. Advanced degree (MS or MBA) preferred.
- Minimum 10 years of experience in Quality Assurance, Quality Engineering, Medical Device Quality, or Combination Product Quality within the pharmaceutical, biotechnology, medical device, or combination product industry.
- Demonstrated experience supporting commercial or late-stage development combination products.
- Experience working with contract manufacturing organizations (CMOs) and device suppliers.
- Experience with injectable combination products, autoinjectors, prefilled syringes, wearable injectors, or drug delivery systems.
- ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent certification preferred.
- Experience supporting FDA, EMA, notified body, or international regulatory inspections.
- Experience with ensuring compliance with applicable combination product regulatory requirements, including 21 CFR Parts 4, 210, 211, 820, ISO 13485, ISO 14971 and other relevant regulations.
- Strong understanding of pharmaceutical GMPs and biologics manufacturing environments.
Compensation StatementThe expected base salary for this position is: $153616.00 to $199501.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Subject to eligibility and applicable plan terms, compensation includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page
