Senior Quality Engineer - Medical Devices & Process Excellence

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

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.