Senior Device Quality Engineer Associate Director

Description

The company makes medicines and vaccines and runs a network of 37 manufacturing sites, supplying 1.7 billion medicine packs and 409 million vaccine doses. Smart manufacturing tools such as robotics, digital solutions and artificial intelligence are used to scale and speed up supply.

This role leads quality engineering for medical device products. You will work with design, manufacturing and regulatory teams to protect product safety, reliability and compliance. The team values people who communicate clearly and solve problems with data and sound judgment.

Responsibilities

• Oversee quality for device design control on new combination products, from early clinical design planning through first commercial launch.
• Support design transfer and scale-up of manufacturing so processes are robust and devices conform to specification.
• Make sure medical devices within combination products meet FDA, ISO, EU MDR, global and company requirements.
• Provide quality oversight of risk management files under ISO 14971 and design and development files under ISO 13485.
• Contribute to the device development process and improvements to the quality management system.
• Lead investigations into quality events, using root cause analysis and corrective action plans.
• Review and approve quality documents such as protocols, test reports and risk management files.
• Track product performance through post-market surveillance and drive ongoing improvement.
• Work with regulatory, supply chain and manufacturing partners on audits and inspections.

Requirements

• Bachelor's degree in biomedical, mechanical or electrical engineering, quality engineering or a related field.
• At least 5 years of experience in medical device quality engineering or regulated manufacturing.
• Working knowledge of medical device quality systems and standards, such as ISO 13485 and FDA 21 CFR part 820.
• Hands-on experience running root cause analysis and CAPA (corrective and preventive action).
• Able to read and review technical drawings, specifications and test data, with strong communication skills and experience working across engineering and operations teams.
• Preferred: an advanced degree in engineering or a quality-related discipline.
• Preferred: experience with risk management standards such as ISO 14971.
• Preferred: familiarity with supplier quality management and supplier audits.
• Preferred: proficiency with statistical tools, design of experiments (DOE) and process capability analysis.
• Preferred: experience supporting regulatory submissions or inspections.
• Skills listed: 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.

Conditions

Hybrid role: regular onsite work in the United States with some remote flexibility.

Travel may be required for supplier visits, audits or cross-site work.

Equal opportunity: the company welcomes candidates from all backgrounds.

Benefits

• Join a team focused on measurable impact for people who need better health outcomes.
• Opportunities to build technical skills, lead important projects and grow your career.
• A comprehensive US benefits program, with details available on the company's benefits summary page.