Senior Quality Engineer - Medical Device Validation

Stryker Group; Portage (MI); On-site; USD 78,000 - 130,000; Full time

Job summary

Stryker Group in Portage, MI is seeking a Senior Quality Engineer to support manufacturing operations, process validation, and continuous improvement activities. You will provide quality engineering expertise across QA, QC, validation, risk management, and compliance to ensure products and processes meet regulatory standards.

You will collaborate with operations, engineering, and quality teams on existing products and new process initiatives.

Qualifications

• Bachelor's degree in Engineering, Science, or a related technical discipline.
• Minimum 2 years of experience in quality, manufacturing, or engineering within a regulated environment.
• Experience with validation activities and risk management tools preferred.
• Experience in the medical device industry is a plus.

Responsibilities

• Review and approve validation and qualification documentation to ensure compliance with regulatory requirements and internal procedures.
• Support quality activities related to nonconformances, CAPA, root cause investigations, and problem-solving efforts.
• Review and approve manufacturing processes, equipment, and product changes through change management processes.
• Support development, execution, and analysis of quality assessments, process qualifications, and validation activities.
• Apply risk management tools to identify and mitigate quality risks.
• Review and approve process and equipment validation protocols, reports, and related documentation.
• Participate in internal and external audits and provide SME support on quality and validation.
• Participate in Kaizen events, Lean initiatives, and continuous improvement projects.

Skills

Lean & Kaizen

Problem-solving

Cross-functional collaboration

Education

Bachelor's degree in Engineering/Science

Tools

FMEA

Fault Tree Analysis

Gauge R&R

Job description

Stryker Group in Portage, MI is seeking a Senior Quality Engineer to support manufacturing operations, process validation, and continuous improvement activities. You will provide quality engineering expertise across QA, QC, validation, risk management, and compliance to ensure products and processes meet regulatory standards.

You will collaborate with operations, engineering, and quality teams on existing products and new process initiatives.