Senior Quality Engineer, Medical Devices - Onsite Kalamazoo

Regulatory Jobs; Kalamazoo (MI); On-site; USD 78,000 - 130,000; Full time

Job summary

Stryker in Kalamazoo, MI is hiring a Senior Quality Engineer to develop and implement methods for process control, inspection, testing, and defect prevention across manufacturing operations. You will partner with operations, engineering, and suppliers to ensure product quality and compliance with regulatory requirements throughout the product lifecycle.

The role emphasizes data-driven quality improvements, root-cause analysis, risk management, and collaboration with cross-functional teams to

Qualifications

• Bachelor’s degree required.
• Minimum 2 years of quality engineering experience in a regulated industry.

Responsibilities

• Develop, implement, and maintain quality methods for process control, inspection, testing, and defect prevention within manufacturing operations.
• Investigate nonconformances, lead root cause analysis, and manage corrective/preventive actions.
• Review nonconforming product through MRB processes including containment and escalation when required.
• Analyze quality data and KPIs to identify trends and address risks.
• Evaluate manufacturing and supplier changes for quality and risk impact prior to implementation.
• Support supplier quality improvement activities and ongoing performance monitoring.
• Apply statistical methods and risk management to support process capability, inspection strategies, and sampling plans.
• Assist audits, transfers, engineering changes, and field-related quality investigations as a subject matter resource.
• Collaborate with manufacturing and engineering to resolve quality issues impacting production.

Skills

Quality engineering

Education

Bachelor’s degree in Engineering, Science, or a related technical field

Job description

Stryker in Kalamazoo, MI is hiring a Senior Quality Engineer to develop and implement methods for process control, inspection, testing, and defect prevention across manufacturing operations. You will partner with operations, engineering, and suppliers to ensure product quality and compliance with regulatory requirements throughout the product lifecycle.

The role emphasizes data-driven quality improvements, root-cause analysis, risk management, and collaboration with cross-functional teams to