Quality Engineer, Service

Stryker is hiring a Quality Engineer - Service to join our Instruments division. This is an onsite position based in Kalamazoo MI.

As the Quality Engineer - Service you will join a team that supports the quality reliability and serviceability of medical devices throughout their lifecycle. This role partners closely with service engineering and operations teams to ensure products processes and repair activities meet quality and regulatory requirements while minimizing customer disruption. You will contribute to quality investigations risk assessments process improvements and validation activities that support service operations across multiple functions.

What You Will Do

• Support quality activities for depot service field service loaner refurbishment and device service operations including validation and nonconformance management.

• Conduct risk assessments on product and process nonconformances to evaluate potential patient and user impact and define appropriate corrective actions.

• Review investigate and document product nonconformances in a timely manner to support efficient product disposition and reduce customer downtime.

• Partner with engineering teams to resolve service-related product issues and support continuity of operations.

• Support product and process validation activities including qualification of new equipment fixtures and service-related processes.

• Develop revise and maintain quality procedures inspection methods and documentation to ensure compliance with regulatory and quality system requirements.

• Analyze operational complaint and customer feedback data and prepare reports and presentations to support quality reviews and decision-making.

• Participate in cross-functional improvement initiatives internal audits and quality investigations to identify and implement process enhancements.

What You Need

• Bachelors degree in Engineering or a related technical discipline

• 0 years experience in engineering

Preferred

• Experience in medical device development manufacturing servicing or another regulated industry environment

• Knowledge of FDA regulations ISO standards and applicable quality system requirements

• Knowledge of risk analysis root cause analysis statistical methods and quality investigation techniques

• ASQ certification including Certified Quality Engineer (CQE) Certified Reliability Engineer (CRE) Certified Manager of Quality/Organizational Excellence (CMQ/OE) or Certified Six Sigma Black Belt (CSSBB)

• USN: $69500 - $110900 USD Annual