Senior Engineer, Quality Assurance

Regulatory Jobs; Portage (MI); Hybrid; USD 100,000 - 140,000; Full time

Job summary

Stryker Corporation in Redmond, WA or Portage, MI is seeking a Senior Quality Assurance Engineer to lead field action assessments and investigations that impact patient safety and product performance. You will drive containment, corrective actions, and CAPA across the product lifecycle in a high-impact, regulated environment.

You will collaborate with R&D, Manufacturing, Regulatory, and Quality teams to ensure compliance with ISO 14971, ISO 13485, and post-market requirements.

Qualifications

• Bachelor’s degree in science, engineering, or related discipline.
• Minimum 2 years of experience in quality assurance or customer quality.
• Experience in a regulated industry, such as medical devices or aerospace.
• Experience conducting post-market quality assessments.

Responsibilities

• Lead product field action assessments from initiation through review and approval, ensuring complete, accurate, and timely documentation.
• Investigate complex product quality issues using structured problem-solving, root cause analysis, and statistical evaluation methods.
• Perform post-market health risk assessments and health hazard evaluations to assess potential product and patient safety risks.
• Develop containment recommendations and corrective actions based on investigation findings, risk assessments, and quality data.
• Author and manage nonconformance and corrective and preventive action records, including defined deliverables, action owners, timelines, and supporting documentation.
• Coordinate investigation and corrective action reviews with Research & Development, Manufacturing, Regulatory, Quality, Marketing, Service, and supplier teams.
• Represent Quality Assurance processes during internal and external audits and maintain compliance with applicable quality system, risk management, and post-market requirements.

Skills

Bachelor’s degree in science/engineer

2+ years QA experience

Regulated industry experience

Post-market QA experience

Education

Bachelor’s degree in science or engineering

Master’s degree in science or engineering

Tools

ISO 14971

ISO 13485

21 CFR Part 820

EU MDR

Job description

Senior Quality Assurance Engineer

Redmond, WA or Portage, MI

Join a team where your expertise directly impacts patient safety and product performance. As a Senior Quality Assurance Engineer, you’ll lead Emergency Care critical investigations and drive improvements that shape the future of medical technology. This is a high-impact role for someone passionate about solving complex problems and ensuring quality excellence across the product lifecycle.

Work Flexibility:

Hybrid: Candidates must reside within a commutable distance to Redmond, WA or Portage, MI, and be able to work onsite several times per week.

What you will do

• Lead product field action assessments from initiation through review and approval, ensuring complete, accurate, and timely documentation.
• Investigate complex product quality issues using structured problem-solving, root cause analysis, and statistical evaluation methods.
• Perform post-market health risk assessments and health hazard evaluations to assess potential product and patient safety risks.
• Develop containment recommendations and corrective actions based on investigation findings, risk assessments, and quality data.
• Author and manage nonconformance and corrective and preventive action records, including defined deliverables, action owners, timelines, and supporting documentation.
• Coordinate investigation and corrective action reviews with Research & Development, Manufacturing, Regulatory, Quality, Marketing, Service, and supplier teams.
• Represent Quality Assurance processes during internal and external audits and maintain compliance with applicable quality system, risk management, and post-market requirements.

What you will need

Required Qualifications

• Bachelor’s degree in science, engineering, or a related discipline.
• Minimum 2 years of experience in quality assurance or customer quality.
• Experience working in a regulated industry, such as medical devices or aerospace.
• Experience conducting post-market quality assessments.

Preferred Qualifications

• Master’s degree in science, engineering, or related discipline.
• Experience conducting product field actions.
• Experience working with ISO 14971, ISO 13485, 21 CFR Part 820, and European Union Medical Device Regulation requirements.
• Six Sigma Green Belt certification or experience with formal investigative techniques.

United States of America Pay Ranges:

• Puerto Rico: $69,500 - $110,900 USD Annual
• USN: $77,700 - $129,500 USD Annual
• US5: $81,600 - $136,000 USD Annual
• US10: $85,500 - $142,500 USD Annual
• US15: $89,400 - $148,900 USD Annual
• US20: $93,200 - $155,400 USD Annual
• US30: $101,000 - $168,400 USD Annual

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

Travel Percentage: 20% Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.