Associate Director, Quality for Drug-Device Combinations

Celldex; Hampton (NJ); On-site; USD 154,000 - 200,000; Full time

Benefits offered by this job

401(k) plan

Health insurance

Job summary

Celldex seeks an Associate Director, Quality Medical Device Engineer to lead quality oversight for drug-device combination products, including prefilled syringes and auto-injectors. You will partner with Technical Operations, Device Development, Regulatory Affairs and external manufacturers to establish and maintain compliant quality systems.

The role requires a strong background in pharma/biotech quality, extensive experience with FDA/ISO requirements, and a proven track record in risk

Qualifications

• Bachelor's degree in Engineering, Biomedical, Mechanical or related field.
• 10+ years in Quality Assurance/Quality Engineering in pharma/biotech/medical devices.
• Experience with FDA/EMA inspections and regulatory requirements for combination products.

Responsibilities

• Lead quality oversight for drug-device combination products and related constituents.
• Provide strategic oversight from concept to commercialization.
• Ensure compliance with FDA 21 CFR Part 4, 820, ISO 13485/14971, and EU MDR.
• Support design controls, risk management, and usability considerations.
• Review DHF, participate in design reviews, and manage supplier quality.
• Drive CAPA, supplier qualification, and quality metrics with CMOs.

Skills

Quality Assurance

Quality Engineering

Regulatory Compliance

FDA/EMA knowledge

Education

Bachelor's degree in Engineering

Advanced degree (MS or MBA) preferred

Tools

ASQ CQE

ASQ CQA

Job description

Celldex seeks an Associate Director, Quality Medical Device Engineer to lead quality oversight for drug-device combination products, including prefilled syringes and auto-injectors. You will partner with Technical Operations, Device Development, Regulatory Affairs and external manufacturers to establish and maintain compliant quality systems.

The role requires a strong background in pharma/biotech quality, extensive experience with FDA/ISO requirements, and a proven track record in risk