Senior Medical Device Quality Engineer - Hybrid QC Focus

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

Job summary

GlaxoSmithKline is seeking a Quality Engineer to oversee device design controls and risk management for medical devices within combination products in the United States.

The role requires coordinating with design, manufacturing, and regulatory teams to ensure safety, reliability, and compliance, with hybrid onsite and remote collaboration and potential travel for supplier visits and audits.

Qualifications

• Bachelor’s degree in biomedical, mechanical, electrical engineering, quality engineering, or equivalent.
• Minimum 5 years in pharmaceutical/biopharmaceutical or related industries, with experience in manufacturing and quality oversight of medical devices or combination products.
• Experience with design controls, risk management, and Design History Files (DHF) / DHF requirements.
• Knowledge of ISO 13485 and FDA 21 CFR part 820.

Responsibilities

• Provide quality oversight of device design control activities from planning through first commercial launch.
• Ensure compliance with FDA, ISO, EU MDR, global, and GSK requirements for medical devices within combination products.
• Review/Approve technical documentation, quality plans, and support new product development and introduction.
• Lead investigations for device nonconformances, deviations, and complaints.
• Lead R&D inspection readiness for device-related areas and act as SME for regulatory inspections and audits.
• Partner with suppliers and internal teams to resolve component quality issues and support supplier quality management.

Skills

Data Integrity

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Pharmaceutical Regulatory Compliance

Problem Solving

Project Management

Quality Assurance (QA)

Quality Management Systems (QMS)

Risk Awareness

Technical Writing

Education

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

Advanced degree in engineering or quality-related discipline

Tools

Statistical tools

DOE

Process capability analysis

Job description

GlaxoSmithKline is seeking a Quality Engineer to oversee device design controls and risk management for medical devices within combination products in the United States.

The role requires coordinating with design, manufacturing, and regulatory teams to ensure safety, reliability, and compliance, with hybrid onsite and remote collaboration and potential travel for supplier visits and audits.