Associate Director, Quality Medical Device Engineer

Scorpion Therapeutics; Hampton (NJ); On-site; USD 150,000 - 185,000; Full time

Job summary

Scorpion Therapeutics is seeking an Associate Director of Quality Medical Device Engineering to oversee quality activities for drug-device combination products, including prefilled syringes and autoinjectors, from development to commercialization.

The role emphasizes leading design control, risk management, and DHF/validation review, with collaboration across Regulatory Affairs, Device Development, and external manufacturers.

Qualifications

• Bachelor's in Engineering or related field; 10+ years QA in pharma/med device quality.
• Experience with combination products, contract manufacturing, and regulatory inspections.
• Background in quality systems and cross-functional collaboration.

Responsibilities

• Serve as SME for quality management and lead design control and risk management.
• Review DHF and validation documentation.
• Support supplier qualification and quality oversight.
• Participate in design reviews and risk assessments.

Skills

Quality management

Design control

Risk management

Regulatory inspections

Education

Bachelor's in Engineering or related field

Job description

Role

Associate Director, Quality Medical Device Engineer, overseeing quality activities for drug-device combination products such as prefilled syringes and autoinjectors, ensuring compliance from development through commercialization.

Responsibilities

• serve as SME for quality management, lead design control and risk management efforts aligned with FDA, ISO, and EU MDR standards, review DHF and validation documentation, support supplier qualification and quality oversight, and participate in design reviews and risk assessments.

Requirements

• Bachelor's in Engineering or related field; 10+ years in QA or medical device quality within pharma, biotech, or med device industries; experience with combination products, contract manufacturing, and regulatory inspections.

Preferred

advanced degree (MS/MBA), certifications like CQE/CQA, and deep knowledge of GMPs, ISO standards, and global regulatory frameworks.

High-Value

focus on injectable combination products, late-stage development or commercial products, GxP compliance, and global regulatory experience.

Collaboration

partner with Technical Operations, Device Development, Regulatory Affairs, and external manufacturers.

Work Setup

not explicitly specified, but implies a senior role with cross-functional involvement.