Senior Quality Engineer - Medical Devices | Process & QA

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

Job summary

Stryker is hiring a Senior Quality Engineer in Kalamazoo, MI to develop and implement quality methods across process control, testing, and inspection. You will investigate nonconformances, lead root-cause analyses, and drive CAPA activities to ensure products meet regulatory quality standards.

You will collaborate with operations, engineering, and suppliers to monitor quality metrics, assess changes, and support audits and transfers throughout the product lifecycle.

Qualifications

• Bachelor's degree in Engineering, Science, or related technical field.
• 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 internal and supplier-related nonconformances; lead root-cause analysis; manage corrective and preventive actions.
• Review and disposition nonconforming product through MRB; include containment and escalation as required.
• Analyze quality data and KPIs; identify trends and address risks.
• Evaluate manufacturing and supplier changes for quality and risk impacts before implementation.
• Support supplier quality improvements and corrective action management.
• Apply statistical methods and risk management to support process capability, inspection strategies, and sampling.
• Support internal/external audits, manufacturing transfers, engineering changes, and field quality investigations.
• Collaborate with manufacturing and engineering to resolve production quality issues.

Skills

Quality engineering

Regulatory industry experience

Statistical process control

Root cause analysis

Education

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

Job description

Stryker is hiring a Senior Quality Engineer in Kalamazoo, MI to develop and implement quality methods across process control, testing, and inspection. You will investigate nonconformances, lead root-cause analyses, and drive CAPA activities to ensure products meet regulatory quality standards.

You will collaborate with operations, engineering, and suppliers to monitor quality metrics, assess changes, and support audits and transfers throughout the product lifecycle.