
Senior Quality Engineer
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At a glance
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Job overview
Stryker is hiring a Senior Quality Engineer. Stryker is seeking a Senior Quality Engineer to ensure products meet quality and regulatory requirements. This role involves developing and implementing methods for process control, improvement, testing, and inspection. The engineer will collaborate with operations, engineering, and suppliers, impacting product quality, supplier performance, and manufacturing process control throughout the product lifecycle.
Key focus areas include 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, and Review, disposition, and document nonconforming product through formal material review processes, including containment and escalation.
Successful candidates bring Bachelor's In Engineering/Science and 2+ Years Quality Experience. Important skills include Quality Methods For Process Control, Inspection, Testing, Defect Prevention, Root Cause Analysis, and Corrective And Preventive Actions. Preferred (not required): U.S. Medical Device Regulatory Requirements, International Medical Device Regulatory Requirements, Nonconformance Investigations, and Corrective Action Activities.
Skills & qualifications
Skills
Qualifications
Benefits
Full 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
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Develop, implement, and maintain quality methods for process control, inspection, testing, and defect prevention within manufacturing operations
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Investigate internal and supplier-related nonconformances, lead root cause analysis, and manage timely corrective and preventive actions in alignment with quality system requirements
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Review, disposition, and document nonconforming product through formal material review processes, including containment and escalation when required
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Analyze quality data and key performance indicators, identify trends, and initiate actions to address emerging product or process risks
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Evaluate manufacturing and supplier changes, including process updates and component changes, to assess quality and risk impacts prior to implementation
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Support supplier quality improvement activities, including corrective action management, part certification initiatives, and ongoing performance monitoring
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Apply statistical methods and risk management practices to support process capability, inspection strategies, and sampling plans
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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
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Bachelor’s degree in Engineering, Science, or a related technical field
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Minimum 2 years of experience in quality , manufacturing , or engineering within a regulated industry
Preferred Qualifications
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Experience working with U.S. and international medical device regulatory requirements
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Experience managing nonconformance investigations and corrective action activities in a regulated quality system
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Experience supporting supplier quality activities or driving manufacturing process improvements in a regulated environment
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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 (https://view.stryker.com/viewer/fcd609f31e39eac44598615224ec7216?iid=69deda99678eb495e0710914#1) 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. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine 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.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
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