Associate Director, Quality Medical Device Engineer

About the role

Celldex, a biotechnology company developing antibody-based therapies for allergic, inflammatory and autoimmune disorders, is hiring an Associate Director, Quality Medical Device Engineer in Hampton, NJ. The role leads quality oversight of drug-device combination products, including prefilled syringes, autoinjectors, on-body delivery systems and related device constituents, partnering with Technical Operations, Device Development, Regulatory Affairs, Clinical, Supply Chain and external manufacturing partners to build compliant quality systems.

Key responsibilities

• Serve as Quality lead and subject matter expert for combination product and medical device constituent quality activities.
• Oversee combination product development programs from concept through commercialization.
• Ensure compliance with FDA 21 CFR Parts 4, 820/QMSR, applicable ISO standards, EU MDR and other global regulations.
• Maintain a compliant combination product quality system aligned with corporate quality objectives.
• Oversee design control, including design planning, inputs/outputs, verification, validation, transfer, design changes and DHF review and approval.
• Take part in design reviews and ensure usability engineering and human factors are considered.
• Lead risk management per ISO 14971 and approve risk assessments, hazard analyses, FMEAs and risk reports.
• Oversee medical device suppliers, contract manufacturers and partners, including qualification, auditing, monitoring, supplier quality agreements and issue resolution.

Required profile

• Bachelor's degree in Engineering, Biomedical, Mechanical or Quality Engineering or a related scientific discipline; advanced degree preferred.
• At least 10 years in QA, Quality Engineering, Medical Device Quality or Combination Product Quality in pharma, biotech or medical devices.
• Demonstrated experience with commercial or late-stage combination products and with CMOs and device suppliers.
• Experience with injectable combination products, autoinjectors, prefilled syringes, wearable injectors or drug delivery systems.
• Preferred: ASQ CQE, CQA or equivalent certification, and experience with FDA, EMA, notified body or international inspections.

Required skills

• Knowledge of 21 CFR Parts 4, 210, 211, 820, ISO 13485 and ISO 14971.
• Strong understanding of pharmaceutical GMPs and biologics manufacturing.

What we offer

• Expected base salary of $153,616 to $199,501.
• Annual discretionary bonus, long-term incentive, 401(k) with employer contribution, health and other insurance, paid holidays, vacation and sick days.