Quality Engineering Lead, Medical Devices – Onsite M-W

Stryker; Portage (MI); Hybrid; USD 110,000 - 183,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) plan

ESPP

Life insurance

Short-term disability

Job summary

Stryker in Portage, MI is seeking an Associate Manager, Quality Engineering to lead a team of Quality Engineers and Technicians, oversee complaint handling, post-market surveillance, and quality systems within a highly regulated medical device environment.

This role focuses on shaping quality strategy, driving KPIs, and partnering across functions to ensure regulatory compliance, product quality, and continuous improvement, with onsite Tue-Wed and optional remote days depending on business needs.

Qualifications

• Bachelor's degree in engineering, science, or related technical field.
• Minimum 6 years of experience in a regulated quality environment.
• Experience with quality systems and regulatory requirements.

Responsibilities

• Own talent strategy including hiring, workforce planning, performance management, and succession planning.
• Lead and develop a team of Quality Engineers and Technicians to achieve quality, compliance, and operational objectives.
• Represents Stryker in customer-facing quality discussions, partnering with sales and field teams to investigate concerns, communicate outcomes, and maintain customer trust.
• Establish and monitor KPIs, quality objectives, and departmental goals.
• Partner with cross-functional teams to investigate, resolve, and communicate customer-impacting quality issues.
• Analyze complaint, warranty, and product quality data to identify trends, emerging risks, and improvement opportunities.
• Lead the development and implementation of complaint handling, post-market surveillance, and quality system processes.
• Support internal and external audits and ensure compliance with regulatory requirements and quality standards.
• Manage departmental budgets and warranty-related costs while driving continuous improvement initiatives.

Skills

Team leadership

Quality assurance

Regulatory compliance

Data analysis

Cross-functional collaboration

Education

Bachelor's degree in engineering/science

Job description

Stryker in Portage, MI is seeking an Associate Manager, Quality Engineering to lead a team of Quality Engineers and Technicians, oversee complaint handling, post-market surveillance, and quality systems within a highly regulated medical device environment.

This role focuses on shaping quality strategy, driving KPIs, and partnering across functions to ensure regulatory compliance, product quality, and continuous improvement, with onsite Tue-Wed and optional remote days depending on business needs.