New · posted Oct 15
STERIS · Medical Devices
Senior Quality Engineer
- Plymouth, MN
- On-site
- Full-time
- Senior & Principal
Open until filled
The role
The Senior Quality Engineer is responsible for managing processes and leading projects to maintain and improve the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP and FDA 21 CFR Part 820/211, EU MDR and other applicable standards. This role leads complaint/CAPA investigations, supplier quality improvement actions, operations production and process control improvements, and product and service quality improvements with the use of statistical techniques and other accepted quality principles. This role plans and executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.
Hours of operation 8am to 5pm, the Senior Quality Engineer is onsite daily.
What STERIS Offers
We value our employees and are committed to providing a comprehensive benefits package that supports your health, wellbeing, and financial future.
What you need
Required
- Bachelor's Degree in Engineering.
- Minimum of 5 years of related experience required. (Manufacturing/Quality Engineering and/or Quality Systems).
- Minimum of 5 years of experience working in an ISO certified environment.
Preferrednice to have
- Experience with medical device or other regulated industries.
- ASQ, QMSR or familiarity with QMSR/GMP regulations.
What you'll do
What You'll do as a Senior Quality Engineer
- Serves as the Core Team Member on cross-functional new product/service development teams with focus on the execution of quality plans and design/service transfer.
- Develops and implements statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis in support of products and service improvements.
- Leads process and product corrective actions and problem-solving activities.
- Reviews the current quality system and recommend / implement improvements as needed.
- Uses data to perform statistical analysis and recommend process / product changes to improve product and service quality.
- Leads projects focused on quality system, product quality and service quality improvements.
- Develops analyses and reports on the performance of the quality system.
- Leads supplier audits and corrective actions.
- Leads and supports internal and external quality system audits.
- Instructs other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
- Collaborates with other departments and facilities within the company on quality related issues.
- Supervises Quality Engineers and other Quality staff in the execution of their assigned duties and objectives.
- Maintains product integrity and quality through the evaluation and disposition of nonconforming materials and processes.
- Perform all other duties as assigned.
Pay and benefits
$95,000 – $118,000 a year
Employer providedPay range for this opportunity is $95,000 to $118,000. This position is eligible for bonus participation.
Here is just a brief overview of what we offer
Market Competitive pay
Extensive Paid Time Off and added Holidays
Excellent Healthcare, Dental and Vision benefits
Long- and Short-Term Disability coverage
401(k) with a company match
Maternity and Paternity Leave
Additional add- on benefits / discounts for programs such as Pet Insurance
Tuition Reimbursement and continuing education programs
Excellent opportunities for advancement in a stable long-term career
#LI- Onsite
Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.
STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits
Open until position is filled.
STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services around the globe. For more information, visit www.steris.com.
If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.
Where you'll work
Plymouth, MNOn-siteOpen in Maps (opens in a new tab)
More jobs in Plymouth, MNEqual opportunity, accessibility and legal noticesSTERIS's statements, word for word
STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.
Job intelligence
The context around this role
Live data · October 15, 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 Minnesota18 roles publishing pay
Senior & Principal roles in the US284 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $95,000 | — | $118,000 |
| Minnesota (middle half) | $92,500 | $99,500 | $106,375 |
| All US (middle half) | $103,375 | $122,750 | $137,500 |
This role: STERIS's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not STERIS's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 22 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk7
- Collaboration and leadership7
- GMP and compliance4
- Investigations and CAPA2
- Documentation and SOPs1
- Regulatory submissions1
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
- FDA and partnersMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program
Company hiring pulse
STERIS on Regulatory Jobs
- 30
- Open roles
- 21
- Distinct roles
- 14
- Locations
By discipline
- Quality28 93%
- Regulatory2 7%
By level
- Associate & Specialist18 60%
- Senior & Principal7 23%
- Manager4 13%
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Senior Quality Engineer at STERIS
Open until filled. $95K–$118K a year, employer provided.