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
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
United States of America Pay Ranges:
USN: $77,700 - $129,500 USD Annual
View 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.