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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
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
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
