Senior Quality Engineer — Remote-Ready MedTech

Stryker Corporation; Portage (MI); On-site; Confidential; Full time

Job summary

Stryker Corporation in Portage, MI is seeking a Senior Quality Engineer to provide quality engineering across QA, QC, validation, risk management, and compliance to ensure products meet regulatory standards. You will support both existing products and new process initiatives within the Prime Stretcher manufacturing value stream, collaborating with operations, engineering, regulatory, and leadership teams.

This role emphasizes driving quality improvements, participating in audits, and applying

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 supporting validation activities in process, equipment, or system validation.
• Experience in the medical device industry.
• Experience with risk management tools such as FMEA or Fault Tree Analysis.
• Knowledge of statistical methods including sampling plans, process capability studies, and Gauge R&R.
• Experience in metal fabrication processes.

Responsibilities

• Review and approve validation and qualification documentation to ensure regulatory and internal compliance.
• Support CAPA, root cause investigations, and problem-solving activities.
• Review and approve manufacturing processes, equipment, and product changes via change management.
• Develop, execute, and analyze quality assessments, process qualifications, and validation activities.
• Apply risk management tools to identify and mitigate quality risks.
• Review and approve validation protocols and reports.
• Contribute to internal and external audits with subject matter expertise.
• Participate in Kaizen, Lean initiatives, and continuous improvement projects to boost product quality and efficiency.

Skills

Quality engineering

Regulated environment

FMEA

Gauge R&R

Statistical methods

Cross-functional collaboration

Metal fabrication

Education

Bachelor's degree in Engineering, Science, or related technical discipline

Job description

Stryker Corporation in Portage, MI is seeking a Senior Quality Engineer to provide quality engineering across QA, QC, validation, risk management, and compliance to ensure products meet regulatory standards. You will support both existing products and new process initiatives within the Prime Stretcher manufacturing value stream, collaborating with operations, engineering, regulatory, and leadership teams.

This role emphasizes driving quality improvements, participating in audits, and applying