Senior Medical Device Quality Engineer – Regulatory & Risk

GSK; United States; Hybrid; USD 110,000 - 150,000; Full time

Benefits offered by this job

Benefits program

Hybrid work model

Career development opportunities

Job summary

GSK seeks a Quality Engineer to ensure medical device and combination product safety, reliability, and compliance through design controls, risk management, and QA activities. You will collaborate with design, manufacturing and regulatory teams to drive quality from development to launch.

The role emphasizes data-driven problem solving, CAPA execution, and inspections readiness within US operations. Hybrid work with onsite collaboration is available; travel may be required.

Qualifications

• Bachelor’s degree required or equivalent in a relevant engineering/quality field.
• Minimum 5 years’ experience in pharmaceutical/biopharmaceutical industries with device quality oversight.
• Experience with design controls, risk management, and DDF/DHF requirements.
• Knowledge of ISO 13485, FDA 21 CFR 820, and quality systems.

Responsibilities

• Provide quality oversight of device design control activities from planning through first commercial launch.
• Oversee risk management files and Design and Development Files (DDF/DHF).
• Review technical documentation, quality plans and support new product development and QMS improvements.
• Lead investigations for device nonconformances, deviations and complaints.
• Collaborate with suppliers and internal teams to resolve component quality issues.

Skills

Data Integrity

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Pharmaceutical Regulatory Compliance

Problem Solving

Project Management

Quality Assurance

Quality Management Systems

Risk Awareness

Technical Writing

Education

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

Job description

GSK seeks a Quality Engineer to ensure medical device and combination product safety, reliability, and compliance through design controls, risk management, and QA activities. You will collaborate with design, manufacturing and regulatory teams to drive quality from development to launch.

The role emphasizes data-driven problem solving, CAPA execution, and inspections readiness within US operations. Hybrid work with onsite collaboration is available; travel may be required.