Senior Engineer, Quality

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

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.

Required Qualifications

What You Will Need

• 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

View the U.S. work location and transparency guide to find the pay range for your location.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short‑term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.