Senior Quality Lead for Drug-Device Combinations

Celldex Therapeutics, Inc.; Hampton (VA); On-site; USD 154,000 - 200,000; Full time

Job summary

Celldex Therapeutics, Inc. is seeking an Associate Director of Quality Medical Device Engineering to lead quality oversight for drug-device combinations.

You will partner across Technical Operations, Regulatory, Clinical, and Supply Chain to establish compliant quality systems for autoinjectors, prefilled syringes, and related devices. The role requires a strong background in Quality Assurance/Quality Engineering for medical devices or combination products, with experience in FDA/EMA inspections

Qualifications

• Bachelor's degree in Engineering or related field is required.
• MS or MBA is preferred for advanced leadership roles.
• Experience in QA/quality engineering for medical devices or combination products is essential.

Responsibilities

• Serve as the Quality SME for combination product and medical device quality activities.
• Provide strategic oversight from concept through commercialization of development programs.
• Ensure compliance with FDA, ISO, EU MDR and related regulatory requirements.
• Support design control activities, risk management, and usability engineering considerations.
• Oversee supplier quality, supplier qualifications, audits, and corrective action processes.

Skills

Quality Assurance

Medical Device Quality

Combination Product Quality

Quality Engineering

Education

Bachelor's degree in Engineering

MS or MBA preferred

Job description

Celldex Therapeutics, Inc. is seeking an Associate Director of Quality Medical Device Engineering to lead quality oversight for drug-device combinations.

You will partner across Technical Operations, Regulatory, Clinical, and Supply Chain to establish compliant quality systems for autoinjectors, prefilled syringes, and related devices. The role requires a strong background in Quality Assurance/Quality Engineering for medical devices or combination products, with experience in FDA/EMA inspections