Quality Engineer, Service

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 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.

Required

What You Need

• 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

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.