Quality Engineer, Service

About the Role

This onsite position in Kalamazoo, MI supports the quality, reliability, and serviceability of medical devices throughout their lifecycle. The 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.

Responsibilities

• 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.

Requirements

• Bachelor’s degree in Engineering or a related technical discipline.
• 0+ years' experience in engineering.

Preferred Qualifications

• 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).

Pay

$69,500 - $110,900 USD Annual

Benefits

• Health benefits: 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: 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.

Depending on customer requirements, employees and new hires in sales and field roles that require access to customer accounts may be required to obtain various vaccinations as an essential function of their role.