Senior Quality Engineer

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

At Stryker, our quality engineers play a critical role in ensuring products consistently meet defined quality and regulatory requirements.

We are hiring a Senior Quality Engineer in Kalamazoo, MI supporting Instruments! In this role, you will develop and implement methods and procedures for process control, process improvement, testing, and inspection to ensure products function as designed and meet established quality standards. You will work closely with operations, engineering, and suppliers, with direct impact across product quality, supplier performance, and manufacturing process control throughout the product lifecycle.

What You Will Do

• 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

What You Will Need

Required Qualifications

• Bachelor's degree in Engineering, Science, or a related technical field
• Minimum 2 years of quality engineering or related quality experience 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 manufacturing process improvements
• Experience applying risk management and statistical process control methods in manufacturing environments

USN: $77,700 - $129,500 USD Annual

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