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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
What You Will Need
Required Qualifications
Bachelor’s 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: $77,700 - $129,500 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Click here to learn more about: US Stryker employee benefits Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
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