Quality Engineer, Service

Job description

Work Flexibility: Onsite 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 Required Bachelor’s 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: $69,500 - $110,900 USD Annual Travel Percentage: 10% Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.