Senior Engineer, Quality

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

Join Stryker as a Senior Quality Engineer in Portage, MI to support manufacturing operations, process validation, and continuous improvement activities. This role provides quality engineering expertise across quality assurance, quality control, validation, risk management, and compliance activities, helping ensure products and processes meet regulatory and quality standards. You will work cross-functionally with operations, engineering, and quality teams to support both existing products and new process initiatives.

This role supports the Prime Stretcher manufacturing value stream, a highly visible product line, and offers the opportunity to drive meaningful quality improvements while partnering closely with operations, engineering, regulatory, and leadership teams.

What You Will Do

• Review and approve validation and qualification documentation to ensure compliance with regulatory requirements and internal procedures.

• Support quality activities related to nonconformances, corrective and preventive actions (CAPA), root cause investigations, and problem-solving efforts.

• Review and approve manufacturing processes, equipment, and product changes through established change management processes.

• Support the development, execution, and analysis of quality assessments, process qualifications, and validation activities.

• Apply risk management tools, including process risk assessments and failure analysis methodologies, to identify and mitigate quality risks.

• Review and approve process and equipment validation protocols, reports, and associated documentation.

• Participate in internal and external audits and provide subject matter expertise related to quality and validation activities.

• Participate in Kaizen events, Lean initiatives, and continuous improvement projects that enhance product quality, manufacturing efficiency, and operational performance.

What You Will Need

Required 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.

Preferred Qualifications

• Experience supporting validation activities, including process, equipment, or system validation.

• Experience within 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 working with Metal Fabrication processes.

USN: $77,700 - $129,500 USD Annual

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