Senior Quality Engineer - Medical Device Validation & QA

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

Benefits offered by this job

Health benefits

401(k) plan

Employee Stock Purchase Plan (ESPP)

Job summary

Stryker in Portage, MI is seeking a Senior Quality Engineer to support manufacturing operations, process validation, and continuous improvement. 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, regulatory, and leadership teams to support existing products and new process initiatives, driving meaningful quality improvements and

Qualifications

• Bachelor's degree in Engineering, Science, or related technical discipline.
• Minimum 2 years of experience in quality, manufacturing, or engineering in a regulated environment.
• Experience with validation activities and medical devices is preferred.
• Knowledge of risk management tools such as FMEA or Fault Tree Analysis.

Responsibilities

• Review and approve validation and qualification documentation to ensure regulatory compliance.
• Support CAPA, root cause investigations and problem-solving activities.
• Review and approve manufacturing processes, equipment, and product changes.
• Develop and analyze quality assessments, process qualifications, and validation activities.
• Apply risk management tools to identify and mitigate quality risks.
• Review validation protocols, reports, and related documentation.
• Participate in internal and external audits and provide QM/specialist expertise.
• Participate in Kaizen events, Lean initiatives, and continuous improvement projects.

Skills

Quality engineering

Cross-functional collaboration

Regulatory compliance

Process improvement

Risk management

Education

Bachelor's degree in Engineering or Science

Tools

FMEA

Fault Tree Analysis

Gauge R&R

Job description

Stryker in Portage, MI is seeking a Senior Quality Engineer to support manufacturing operations, process validation, and continuous improvement. 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, regulatory, and leadership teams to support existing products and new process initiatives, driving meaningful quality improvements and