New · posted Oct 21
Stryker · Medical Devices
Senior Engineer, Quality Assurance
- Portage, MI
- Hybrid
- Full-time
- Senior & Principal
Open until filled
The role
Work Flexibility: Hybrid
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 for the Belfast, Northern Ireland site that shapes 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 commuting distance of Portage, MI and be able to work onsite several days per week.
What you 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 Qualificationsnice to have
- 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.
$77,700 - $129,500 USD Annual
What you'll 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.
Pay
$77,700 – $129,500 a year
Employer providedWhere you'll work
Portage, MIHybridOpen in Maps (opens in a new tab)
More jobs in Portage, MIEqual opportunity, accessibility and legal noticesStryker's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 21, 2026
Salary intelligence
How the pay compares
This role's midpoint is 13% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in Michigan14 roles publishing pay
Senior & Principal roles in the US303 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $77,700 | — | $129,500 |
| Michigan (middle half) | $104,000 | $114,750 | $119,000 |
| All US (middle half) | $102,750 | $119,000 | $137,500 |
This role: Stryker's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 21, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 904 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Stryker's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 19 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Investigations and CAPA6
- Quality systems and risk5
- Collaboration and leadership3
- GMP and compliance2
- Documentation and SOPs2
- Lab testing and methods1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Risk management for medical devices
Company hiring pulse
Stryker on Regulatory Jobs
- 64
- Open roles
- 52
- Distinct roles
- 18
- Locations
By discipline
- Quality51 80%
- Regulatory11 17%
- Compliance & Safety2 3%
By level
- Senior & Principal38 59%
- Associate & Specialist19 30%
- Manager7 11%
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Senior Engineer, Quality Assurance at Stryker
Open until filled. $78K–$130K a year, employer provided.