Quality Engineer – Service, Medical Devices

Stryker; Kalamazoo (MI); On-site; USD 70,000 - 111,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Employee Stock Purchase Plan (ESPP)

Short-term disability insurance

Wellbeing program

Job summary

Stryker is hiring a Quality Engineer - Service in Kalamazoo, MI, to support the Instruments division. The role focuses on quality, reliability, and serviceability of medical devices across their lifecycle and collaborates with service, engineering, and operations to ensure regulatory compliance and minimize downtime.

You will lead risk assessments, investigations, and process improvements, participate in validations, and help drive continuous quality improvement initiatives within a on-site,

Qualifications

• Bachelor’s degree in Engineering or related technical discipline.
• 0+ years' experience in engineering.
• Experience in medical device development or regulated environment is preferred.
• Knowledge of FDA regulations and ISO standards is preferred.
• ASQ certifications (CQE/CRE/CMQ/OE/CSSBB) are a plus.

Responsibilities

• Support 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 patient and user impact and define corrective actions.
• Investigate and document product nonconformances to support 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 and service-related processes.
• Develop and maintain quality procedures, inspection methods, and documentation for regulatory compliance.
• Analyze data from operations, complaints, and customer feedback to support quality reviews and decision-making.
• Participate in cross-functional improvement initiatives, audits, and quality investigations.

Skills

Regulatory knowledge

Risk analysis

Root cause analysis

Statistical methods

Education

Bachelor’s degree in Engineering or related technical discipline

Job description

Stryker is hiring a Quality Engineer - Service in Kalamazoo, MI, to support the Instruments division. The role focuses on quality, reliability, and serviceability of medical devices across their lifecycle and collaborates with service, engineering, and operations to ensure regulatory compliance and minimize downtime.

You will lead risk assessments, investigations, and process improvements, participate in validations, and help drive continuous quality improvement initiatives within a on-site,