Senior Quality Engineer

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

What You Will Need

Required Qualifications

• Bachelors 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

USN: $77700 - $129500 USD Annual

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