Senior Medical Device Quality Engineer – Hybrid, High Impact

Regulatory Jobs; Lower Providence Township (PA); Hybrid; USD 90,000 - 130,000; Full time

Job summary

GSK US is seeking a Quality Engineer for medical device products across design, manufacturing, and regulatory teams. You will ensure product safety, reliability, and compliance while leveraging data-driven problem solving and cross-functional collaboration to improve patient outcomes.

This hybrid role requires a bachelor's in engineering or quality, 5+ years in medical device quality engineering or regulated manufacturing, knowledge of ISO 13485 and FDA 21 CFR part 820, and experience with

Qualifications

• Bachelor's degree in a relevant engineering or quality discipline.
• 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 root cause analysis and CAPA execution.
• Ability to read and review technical drawings, specs, and test data; cross-functional collaboration.

Responsibilities

• Provide quality oversight of device design control activities from planning to launch.
• Support design transfer and manufacturing scale-up for robust processes.
• Ensure compliance with FDA, ISO, EU MDR, and GSK requirements for devices.
• Oversee risk management files (ISO 14971) and DDs (ISO 13485).
• Contribute to QMS improvements.
• Lead investigations into quality events using RCA and CAPA.
• Review quality documents, protocols, test reports, and risk files.
• Monitor product performance via post-market surveillance and drive improvement.
• Collaborate with regulatory, supply chain, and manufacturing for audits.

Skills

Quality engineering

Root cause analysis

CAPA execution

Cross-functional collaboration

Technical reading skills

Education

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

Job description

GSK US is seeking a Quality Engineer for medical device products across design, manufacturing, and regulatory teams. You will ensure product safety, reliability, and compliance while leveraging data-driven problem solving and cross-functional collaboration to improve patient outcomes.

This hybrid role requires a bachelor's in engineering or quality, 5+ years in medical device quality engineering or regulated manufacturing, knowledge of ISO 13485 and FDA 21 CFR part 820, and experience with