Senior Medical Device Quality Engineer – Design Control & Compliance

GlaxoSmithKline; Upper Providence (Delaware County); On-site; USD 95,000 - 130,000; Full time

Job summary

GlaxoSmithKline in the United States seeks a Quality Engineer for medical device products. You will lead quality engineering across design, manufacturing and regulatory teams to ensure product safety, reliability and compliance.

You will use data and root cause analysis to drive improvements and protect patient outcomes in a multidisciplinary environment. The role is hybrid, based in the US with onsite collaboration and some remote work.

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 quality systems and standards relevant to medical devices, such as 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 communication skills and experience working cross-functionally with engineering and operations teams.

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 relevant 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).
• Support and contribute to device development process and QMS improvements.
• Lead investigations into quality events, using root cause analysis and corrective action plans.
• 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

Quality engineering

Root cause analysis

CAPA

Cross-functional communication

Technical writing

Data analysis

Problem solving

Project management

QA

QMS

Risk management

Reading drawings

Education

Bachelor's degree in biomedical, mechanical, electrical engineering, quality engineering

Tools

Statistical tools

Design of Experiments (DOE)

Process capability analysis

ISO 13485

FDA 21 CFR 820

Job description

GlaxoSmithKline in the United States seeks a Quality Engineer for medical device products. You will lead quality engineering across design, manufacturing and regulatory teams to ensure product safety, reliability and compliance.

You will use data and root cause analysis to drive improvements and protect patient outcomes in a multidisciplinary environment. The role is hybrid, based in the US with onsite collaboration and some remote work.