Senior Device Quality Engineer Associate Director

GSK•Upper Providence, PA

2d•Hybrid

About The Position

You will lead quality engineering activities for medical device products. You will work across design, manufacturing, and regulatory teams to ensure product safety, reliability, and compliance. We value clear communicators who solve problems with data and practical judgment. You will grow your career by influencing product quality and patient outcomes while working with talented, multidisciplinary teams aligned to our mission of uniting science, technology and talent to get ahead of disease together.

Requirements

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 (corrective and preventive action) 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.

Nice To Haves

Advanced degree in engineering or quality-related discipline.
Experience with risk management standards such as ISO 14971.
Familiarity with supplier quality management and supplier audits.
Proficiency with statistical tools, design of experiments (DOE), and process capability analysis.
Experience supporting regulatory submissions or inspections.

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.