Senior Quality Engineer, Medical Devices – Onsite Kalamazoo

Stryker Corporation; Portage (MI); Hybrid; USD 89.000 - 149.000; Vollzeit

Zusammenfassung

Stryker Corporation in Kalamazoo, Michigan, seeks a Staff Quality Engineer to support product and process quality across instruments manufacturing in Portage. You will partner with operations, engineering, suppliers, and quality teams to drive compliance and resolve quality issues.

Lead investigations and timely closure of non-conformances and CAPAs; review MRB dispositions; collaborate with suppliers on quality improvements; ensure changes meet regulatory and quality requirements.

Qualifikationen

• Bachelor's degree in Engineering, Science, or a related technical discipline.
• Minimum 4 years of quality or manufacturing engineering experience.
• Experience supporting non-conformance investigations and CAPAs.
• Preferred: medical device industry exposure and statistical analysis skills.
• Six Sigma or equivalent process improvement knowledge is advantageous.

Aufgaben

• Partner with operations, engineering, and quality teams to monitor and improve quality.
• Lead investigations and closure of nonconformances and CAPAs with root-cause analysis.
• Review and disposition nonconforming materials via MRB processes.
• Collaborate with suppliers to drive quality improvements and corrective actions.
• Evaluate changes for regulatory and quality compliance and support process validation.

Kenntnisse

Quality engineering

Manufacturing engineering

Statistical methods

GD&T

CAPA

Root cause analysis

Supplier collaboration

Ausbildung

Bachelor's degree in Engineering or Science

Tools

GD&T

CMM

Measurement systems

Jobbeschreibung

Stryker Corporation in Kalamazoo, Michigan, seeks a Staff Quality Engineer to support product and process quality across instruments manufacturing in Portage. You will partner with operations, engineering, suppliers, and quality teams to drive compliance and resolve quality issues.

Lead investigations and timely closure of non-conformances and CAPAs; review MRB dispositions; collaborate with suppliers on quality improvements; ensure changes meet regulatory and quality requirements.