Senior Quality Engineer

Regulatory Jobs; Kalamazoo (MI); On-site; USD 78,000 - 130,000; Full time

Job summary

Stryker in Kalamazoo, MI is hiring a Senior Quality Engineer to develop and implement methods for process control, inspection, testing, and defect prevention across manufacturing operations. You will partner with operations, engineering, and suppliers to ensure product quality and compliance with regulatory requirements throughout the product lifecycle.

The role emphasizes data-driven quality improvements, root-cause analysis, risk management, and collaboration with cross-functional teams to

Qualifications

• Bachelor’s degree required.
• Minimum 2 years of quality engineering experience in a regulated industry.

Responsibilities

• Develop, implement, and maintain quality methods for process control, inspection, testing, and defect prevention within manufacturing operations.
• Investigate nonconformances, lead root cause analysis, and manage corrective/preventive actions.
• Review nonconforming product through MRB processes including containment and escalation when required.
• Analyze quality data and KPIs to identify trends and address risks.
• Evaluate manufacturing and supplier changes for quality and risk impact prior to implementation.
• Support supplier quality improvement activities and ongoing performance monitoring.
• Apply statistical methods and risk management to support process capability, inspection strategies, and sampling plans.
• Assist audits, transfers, engineering changes, and field-related quality investigations as a subject matter resource.
• Collaborate with manufacturing and engineering to resolve quality issues impacting production.

Skills

Quality engineering

Education

Bachelor’s degree in Engineering, Science, or a related technical field

Job description

Work Flexibility: Onsite

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

USN: $77,700 - $129,500 USD Annual

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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.