Stryker

Workplace Flexibility: Candidate must reside within a commutable distance to Portage, Michigan but is expected to be onsite at the facility multiple times/week.

What you will do

• Lead, develop, and engage a high‑performing Advanced Quality Engineering team, including recruiting top talent, driving performance, and providing ongoing coaching and feedback.

• Oversee the development, coordination, and continual improvement of QA systems supporting new product development and business growth initiatives.

• Provide strategic Quality leadership across cross‑functional NPD teams, ensuring alignment with regulatory requirements, design controls, and QMS standards.

• Direct Quality‑owned deliverables such as risk management, human factors engineering, design verification/validation, and compliance activities.

• Guide process development and PPAP execution to ensure robust manufacturing readiness and supplier quality.

• Train cross‑functional teams on QA, GMP, and Design Control practices to elevate organizational capability.

• Operate autonomously, making sound business decisions while maintaining a high level of team engagement and accountability.

What you need

Required

• Bachelor’s degree

• Minimum of 6 years of experience in a regulated environment, preferably within RA/QA, engineering, or related technical disciplines.

Preferred

• Bachelor’s degree in mechanical, electrical, or biomedical engineering, or related discipline.

• Demonstrated leadership experience managing teams, including responsibility for recruiting, performance management, and employee development.

• Experience in new product development, including design controls, risk management, human factors engineering (HFE), and application of regulatory requirements such as ISO standards, FDA regulations, and international guidelines.

• Demonstrated technical expertise in medical device product lines, with proficiency in quality concepts (CAPA, audits, statistics), process improvement, and trending/analysis reporting.