Staff Quality Engineer

Regulatory Jobs; Portage (MI); On-site; USD 89,000 - 149,000; Full time

Job summary

Stryker is seeking a Staff Quality Engineer to support product and process quality across manufacturing operations for Instruments in Portage, Michigan. 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.

The role involves leading continuous improvement initiatives, audits, and CAPA activities to ensure regulatory and quality requirements are met, with travel as needed.

Qualifications

• Bachelor's degree in Engineering, Science, or related technical field.
• Minimum 4 years in quality/manufacturing engineering.
• Experience with non-conformance investigations, CAPA, or QMS.
• Medical device industry experience preferred.
• Experience with quality data analysis using statistics.
• Six Sigma Green Belt or Black Belt preferred.
• GD&T and metrology equipment experience.

Responsibilities

• Monitor and improve product and process quality across manufacturing operations.
• Support transfer, launch, and scale-up of new products and processes, ensuring production readiness.
• Lead investigations and timely closure of non-conformances and CAPAs with root cause analysis.
• Review and disposition nonconforming materials and products through MRB processes.
• Collaborate with suppliers to address quality issues and support supplier quality improvements.
• Evaluate manufacturing, supplier, and engineering changes for compliance.
• Monitor quality metrics, analyze trends, and drive corrective actions.

Skills

Quality engineering

Data analysis

Statistical methods

CAPA

Education

Bachelor's degree in Engineering/Science

Tools

GD&T

CMMs

Calipers

Job description

Work Flexibility: Onsite

Stryker is seeking a Staff 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.

• 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.

• Lead or 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 4 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 Annual

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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.