Senior Quality Engineer

Stryker Corporation; Portage (MI); On-site; USD 89,000 - 149,000; Full time

Job summary

Stryker Corporation in Kalamazoo, MI is seeking a Senior Quality Engineer to strengthen product and process quality across manufacturing operations for Instruments. You will partner with operations, engineering, suppliers, and quality teams to drive compliance and resolve quality issues, while supporting new product introductions and scale-up activities.

Responsibilities include leading non-conformance investigations and CAPAs, reviewing disposition of nonconforming materials, and collaborating

Qualifications

• Bachelor’s degree in engineering/science required.
• Minimum 2 years in quality/manufacturing engineering.
• Experience with non-conformance investigations and CAPAs.

Responsibilities

• Partner with manufacturing, engineering and quality teams to improve quality performance.
• Support transfer, launch and scale-up of new products and processes.
• Lead investigations and corrective actions for root cause analysis.
• Review disposition of nonconforming materials via MRB.
• Collaborate with suppliers on quality improvements and supplier CAPAs.

Skills

Quality engineering

Root cause analysis

Statistical methods

Process improvement

Audit involvement

Education

Bachelor's degree in Engineering/Science

Tools

GD&T

Calipers

Micrometers

CMMs

Metrology equipment

Job description

## Senior Quality EngineerApply: Kalamazoo, Michigan: Full time: Posted Yesterday: R574291Work Flexibility: OnsiteStryker is seeking a **Senior Quality Engineer** to support product and process quality across manufacturing operations for **Instruments** in **Portage, Michigan**. In this role, you will partner with operations, engineering, suppliers, and quality teams to drive compliance, resolve quality issues, support new product introductions and manufacturing scale up activities, lead continuous improvement initiatives, and ensure products meet applicable regulatory and quality requirements. **What You Will Do*** Partner with manufacturing, engineering, and quality teams to monitor and improve product and process quality performance.* Support the transfer, launch, and scale-up of new products and manufacturing processes, partnering cross-functionally to establish robust quality systems and ensure successful production readiness.* Support or lead investigations and timely closure of non-conformances and corrective and preventive actions, including root cause analysis and implementation of corrective actions.* Review and disposition nonconforming materials and products through Material Review Board processes.* Collaborate with suppliers to address quality issues, manage supplier corrective actions, and support supplier quality improvement initiatives.* Evaluate and support manufacturing, supplier, and engineering changes to ensure compliance with quality and regulatory requirements.* Monitor quality performance indicators, analyze trends, and implement actions to address identified risks and improvement opportunities.* Support continuous improvement initiatives focused on quality enhancement, scrap reduction, efficiency gains, and cost savings.* Support process validation, equipment qualification, inspection methods, measurement system analysis, and statistical process controls.* Participate in internal and external audits, complaint investigations, field actions, and continuous improvement projects across manufacturing operations. **What You Will Need****Required Qualifications*** Bachelor's degree in Engineering, Science, or a related technical discipline.* Minimum 2 years of quality engineering, manufacturing engineering, or related engineering experience.* Experience supporting non-conformance investigations, corrective and preventive actions, or quality management systems. **Preferred Qualifications*** Experience in the medical device industry.* Experience analyzing quality data and applying statistical methods to support manufacturing or process improvements.* Six Sigma Green Belt or Six Sigma Black Belt certification.* Experience with geometric dimensioning and tolerancing (GD&T).* Experience using metrology equipment such as calipers, micrometers, pin gauges, or coordinate measuring machines (CMMs).**USN**: $89,300 - $148,800 USD AnnualView the U.S. work location and transparency guide to find the pay range for your location. Travel Percentage: 20%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.