Associate Director, Quality - Medical Devices

Celldex Therapeutics, Inc.; Hampton (NJ); In loco; USD 154.000 - 200.000; Tempo pieno

Descrizione del lavoro

Celldex Therapeutics, Inc. seeks an Associate Director, Quality Medical Device Engineer to lead quality oversight for drug-device combinations, including prefilled syringes and autoinjectors.

You will partner with Technical Operations, Regulatory Affairs, Clinical, Supply Chain and external manufacturers to build and maintain compliant quality systems guiding development and commercialization. The role emphasizes design control, risk management per ISO 14971, supplier management, and regulatory

Competenze

• Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, Quality Engineering, or related scientific discipline required.
• Advanced degree (MS or MBA) preferred.

Mansioni

• Lead quality oversight for combination product and medical device constituent activities.
• Provide strategic oversight from concept through commercialization.
• Ensure compliance with FDA, ISO, and EU requirements and QMS.

Conoscenze

Quality engineering

Regulatory compliance

Design control

Risk management

Supplier management

Regulatory inspections

Formazione

Bachelor's degree in Engineering or related field

Advanced degree (MS or MBA) preferred

Strumenti

Descrizione del lavoro

Celldex Therapeutics, Inc. seeks an Associate Director, Quality Medical Device Engineer to lead quality oversight for drug-device combinations, including prefilled syringes and autoinjectors.

You will partner with Technical Operations, Regulatory Affairs, Clinical, Supply Chain and external manufacturers to build and maintain compliant quality systems guiding development and commercialization. The role emphasizes design control, risk management per ISO 14971, supplier management, and regulatory