Senior Device Quality Engineer Associate Director

Business Introduction:

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bring our innovations to patients as quickly, efficiently and effectively as possible.

Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

Position Summary:

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.

Key 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.

Basic 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 (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.

Preferred Qualifications:

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.

Work Arrangement:

This role is hybrid, with regular onsite collaboration in the United States and some remote flexibility. Travel may be required for supplier visits, audits, or cross-site collaboration.

What we offer you:

You will join a team focused on meaningful, measurable impact for people who need better health outcomes. You will receive opportunities to…