Associate Director, Medical Device Quality

GSK; Upper Providence (Delaware County); Hybrid; USD 117,000 - 143,000; Full time

Job summary

GSK in the United States is seeking a Quality Engineer to lead device quality activities for medical devices within combination products. You will collaborate across design, manufacturing, and regulatory teams to ensure safety, reliability, and compliance, influencing patient outcomes through data-driven decisions.

The role requires 5+ years in medical device quality engineering, knowledge of ISO 13485 and FDA 21 CFR Part 820, and hands-on CAPA/root cause expertise.

Qualifications

• Bachelor’s degree in biomedical, mechanical, electrical engineering, quality engineering, or related field.
• Minimum 5 years’ experience in medical device quality engineering or regulated manufacturing.
• Working knowledge of ISO 13485 and FDA 21 CFR part 820.
• Hands-on experience with root cause analysis and CAPA execution.
• Ability to read and review technical drawings, specifications, and test data; strong cross-functional communication.

Responsibilities

• Provide quality oversight of device design control activities for new combination products from clinical design planning through first commercial product launch.
• Support design transfer and manufacturing scale-up to ensure robust processes and device conformity.
• Ensure compliance with FDA, ISO, EU MDR, global, and GSK requirements for medical devices within combination products.
• Provide quality oversight of risk management files (ISO 14971) and Design and Development Files (ISO 13485).
• Lead investigations into quality events using root cause analysis and corrective actions.
• Review and approve quality documents including protocols, test reports, and risk management files.
• Monitor product performance through post-market surveillance and drive continuous improvement.
• Collaborate with regulatory, supply chain, and manufacturing partners to support audits and inspections.

Skills

Root cause analysis

CAPA execution

Cross-functional collaboration

Technical communication

Reading drawings & specs

Education

Bachelor’s degree in biomedical, mechanical, electrical engineering, quality engineering, or related field

Advanced degree in engineering or quality-related discipline

Tools

Statistical tools

Design of Experiments (DOE)

Process capability analysis

Job description

GSK in the United States is seeking a Quality Engineer to lead device quality activities for medical devices within combination products. You will collaborate across design, manufacturing, and regulatory teams to ensure safety, reliability, and compliance, influencing patient outcomes through data-driven decisions.

The role requires 5+ years in medical device quality engineering, knowledge of ISO 13485 and FDA 21 CFR Part 820, and hands-on CAPA/root cause expertise.