Senior Quality Engineer - Medical Devices Process QA

Regulatory Jobs; 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 methods for process control, testing, and inspection ensuring products meet quality standards. Collaborate with operations, engineering, and suppliers to impact product quality and manufacturing processes.

Responsibilities include leading root cause analyses of nonconformances, managing corrective actions, applying statistical methods, and supporting audits and supplier quality activities.

Qualifications

• Bachelor’s degree in Engineering, Science, or a related technical field.
• Minimum 2 years of quality engineering 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, 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
• Collaborate closely with manufacturing and engineering teams to identify, investigate, and resolve quality issues impacting production

Skills

Quality engineering

Regulated industry

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 methods for process control, testing, and inspection ensuring products meet quality standards. Collaborate with operations, engineering, and suppliers to impact product quality and manufacturing processes.

Responsibilities include leading root cause analyses of nonconformances, managing corrective actions, applying statistical methods, and supporting audits and supplier quality activities.