Senior Quality Engineer
Stryker
Senior Quality Engineer
Job Description
Work Flexibility: OnsiteAt 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 DoDevelop, implement, and maintain quality methods for process control, inspection, testing, and defect prevention within manufacturing operationsInvestigate internal and supplier-related nonconformances, lead root cause analysis, and manage timely corrective and preventive actions in alignment with quality system requirementsReview, disposition, and document nonconforming product through formal material review processes, including containment and escalation when requiredAnalyze quality data and key performance indicators, identify trends, and initiate actions to address emerging product or process risksEvaluate manufacturing and supplier changes, including process updates and component changes, to assess quality and risk impacts prior to implementationSupport supplier quality improvement activities, including corrective action management, part certification initiatives, and ongoing performance monitoringApply statistical methods and risk management practices to support process capability, inspection strategies, and sampling plansSupport internal and external audits, manufacturing transfers, engineering changes, and field-related quality investigations as a subject matter resourceWhat You Will NeedRequired QualificationsBachelor’s degree in Engineering, Science, or a related technical fieldMinimum 2 years of experience in quality, manufacturing, or engineering within a regulated industryPreferred QualificationsExperience working with U.S. and international medical device regulatory requirementsExperience managing nonconformance investigations and corrective action activities in a regulated quality systemExperience supporting supplier quality activities or driving manufacturing process improvements in a regulated environmentExperience applying risk management and statistical process control methods in manufacturing environments USN: $77,700 - $129,500 USD AnnualView the U.S. work location and transparency guide to find the pay range for your location. Travel Percentage: 10%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.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
Locations
- Kalamazoo 6201 South Sprinkle Rd, Michigan
Salary
77,700 - 129,500 USD / yearly
Skills Required
- qualityintermediate
Required Qualifications
- Bachelor’s degree in Engineering, Science, or a related technical field (degree in engineering)
- Minimum 2 years of experience in quality, manufacturing, or engineering within a regulated industry (experience, 2 years)
- Bachelor’s degree in Engineering, Science, or a related technical field (degree in engineering)
- Minimum 2 years of experience in quality, manufacturing, or engineering within a regulated industry (experience, 2 years)
Preferred Qualifications
- Experience working with U.S. and international medical device regulatory requirements (experience)
- Experience managing nonconformance investigations and corrective action activities in a regulated quality system (experience)
- Experience supporting supplier quality activities or driving manufacturing process improvements in a regulated environment (experience)
- Experience applying risk management and statistical process control methods in manufacturing environments (experience)
- Experience working with U.S. and international medical device regulatory requirements (experience)
- Experience managing nonconformance investigations and corrective action activities in a regulated quality system (experience)
- Experience supporting supplier quality activities or driving manufacturing process improvements in a regulated environment (experience)
- Experience applying risk management and statistical process control methods in manufacturing environments (experience)
- USN: $77,700 - $129,500 USD Annual (experience)
- View the U.S. work location and transparency guide to find the pay range for your location. (experience)
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
- 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
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