Senior Quality Engineer

About the role

Our quality engineers at Stryker play a critical role in ensuring products consistently meet defined quality and regulatory requirements. We are now hiring a Senior Quality Engineer in Kalamazoo, MI to support Instruments.

Responsibilities

• Develop, implement, and maintain quality methods for process control, inspection, testing, and defect prevention within manufacturing operations
• Investigate internal and supplier-related nonconformances, lead root cause analysis, and manage timely corrective and preventive actions in alignment with quality system requirements
• Review, disposition, and document nonconforming product through formal material review processes, including containment and escalation when required
• Analyze quality data and key performance indicators, identify trends, and initiate actions to address emerging product or process risks
• Evaluate manufacturing and supplier changes, including process updates and component changes, to assess quality and risk impacts prior to implementation
• Support supplier quality improvement activities, including corrective action management, part certification initiatives, and ongoing performance monitoring
• Apply statistical methods and risk management practices to support process capability, inspection strategies, and sampling plans
• Support internal and external audits, manufacturing transfers, engineering changes, and field-related quality investigations as a subject matter resource

Requirements

• Bachelor’s degree in Engineering, Science, or a related technical field
• Minimum 2 years of experience in quality, manufacturing, or engineering within a regulated industry

Preferred Qualifications

• Experience working with U.S. and international medical device regulatory requirements
• Experience managing nonconformance investigations and corrective action activities in a regulated quality system
• Experience supporting supplier quality activities or driving manufacturing process improvements in a regulated environment
• Experience applying risk management and statistical process control methods in manufacturing environments

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