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New · posted Nov 6

STERIS · Medical Devices

Quality Engineer II

  • Eden Prairie, MN
  • On-site
  • Full-time
  • Senior & Principal
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Pay$86K–$111K
EmploymentFull-time
LocationEden Prairie, MN
LevelSenior & Principal
FunctionQuality Engineering
DeadlineOpen until filled

The role

The Quality Engineer II in our Eden Prairie, MN location is responsible for maintaining and improving the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable standards. This role supports complaint/CAPA investigations, supplier quality improvement, operations production and process controls, and product and service quality improvement with the use of statistical techniques and other accepted quality principles. This role executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.

This position requires that you work onsite in our Eden Prairie facility Monday through Friday during core business hours 7am to 4 pm or 8am to 5pm. 

Must be available for occasional early morning calls with team in Germany.

Other

  • Shares technical knowledge with others in the team.
  • Identifies technical problems and provides innovative solutions.
  • Generates alternatives and takes reasonable risks while solving technical problems.
  • Generates detailed, high-quality technical documentation to capture and communicate designs.
  • Completes tasks on time with minimal supervision while identifying potential risks.
  • Drives improvements in processes for better efficiency.
  • Utilizes advanced tools and best practices to track product and process metrics.
  • Mentors team members on timely task completion and actively participates in brainstorming sessions.

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 3 years of related experience required (Manufacturing/Quality Engineering and/or Quality Systems).
  • 3+ years of experience working in an ISO certified environment.
  • Experience with medical device or other regulated industries.
  • Ability to travel to local supplier sites up to 10%.

Preferrednice to have

  • ASQ, Certification, preferred.
  • Quality Management System Regulation FDA (QMSR) Certification or familiarity with QMSR/GMP regulations.
  • Knowledge of Track Wise, Windchill PLM, Grand Avenue or other similar systems.
  • Experience with supplier controls, supplier audits or supplier monitoring.
  • Knowledge of ISO 13485 regulations.

Skills named in this posting

What you'll do

What You'll do as a Quality Engineer II

  • Participate on cross-functional new product development teams with focus on product/ service quality and Quality System compliance.
  • Develop and implement statistically valid sampling plans, design experiments, capability studies, SPC and trend analysis.
  • Initiate and/or participate in process and product corrective actions and problem-solving activities.
  • Update/establish documented work instructions as needed.
  • Review collected data to perform statistical analysis and recommend process/product changes to improve quality.
  • Monitor and report on performance metrics.
  • Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
  • Collaborate with other departments and facilities within the company on quality related issues.
  • Maintain product integrity and quality through support of evaluation and disposition of nonconforming materials.
  • Perform quality system audits and provide guidance on corrective actions.
  • Perform other duties as assigned.

Pay and benefits

$86,063 – $111,375 a year

Employer provided
How this compares

Pay range for this opportunity is $86,062.50 - $111,375.00. 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

Eden Prairie, MNOn-siteOpen in Maps (opens in a new tab)

More jobs in Eden Prairie, MN
Equal 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 · November 6, 2026

Salary intelligence

How the pay compares

This role's midpoint is 20% below the US median for Quality Engineering roles at this level.

This roleEmployer provided

$86,063 to $111,375 a year

Senior & Principal roles in Minnesota13 roles publishing pay

Middle half $94,000 to $113,500, median $100,000

Senior & Principal roles in the US100 roles publishing pay

Middle half $105,375 to $143,500, median $124,000
Annual base pay
Annual base payLowMedianHigh
This role$86,063—$111,375
Minnesota$94,000$100,000$113,500
All US$105,375$124,000$143,500

This role: STERIS's own published range. Comparisons: the base pay employers published on open Quality Engineering roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Quality Engineering

The general path across 213 open Quality Engineering roles on Regulatory Jobs, with the titles they carry most. Not STERIS's own promotion track.

  1. One step back

    Associate & Specialist

    Often: Quality Engineer · Associate Quality Engineer

    $84K median65 open

  2. This role

    Senior & Principal

    Often: Quality Engineer · Senior Quality Engineer

    $124K median137 open

  3. Next step

    Manager

    Often: Quality Engineering Manager · Senior Manager, Quality Engineering

    $189K median9 open

  4. Later

    Director

    Often: Associate Director, Quality Medical Device Engineer · Sr. Engineering Program Director, Quality Strategy & Investigation Excellence

    2 open

Skills DNA

What this role leans on

How many of the posting's 33 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 6 linesDocumentation and SOPs: 3 linesInvestigations and CAPA: 2 linesRegulatory submissions: 1 lineQuality systems and risk: 8 linesCollaboration and leadership: 6 linesGMPDocumentationInvestigationsSubmissionsQuality systemsTeamwork
  • Quality systems and risk8
  • GMP and compliance6
  • Collaboration and leadership6
  • Documentation and SOPs3
  • Investigations and CAPA2
  • Regulatory submissions1

Regulatory intelligence

The rules, regulations and standards behind this role

The regulations, guidance and standards that govern Quality Engineering work in medical devices, led by the five this posting names, each linked to the agency or standards body that publishes it.

From Regulatory News

Manufacturing and quality coverage for this profession

Company hiring pulse

STERIS on Regulatory Jobs

38
Open roles
38
Distinct roles
16
Locations

By discipline

  • Quality35 92%
  • Regulatory3 8%

By level

  • Associate & Specialist21 55%
  • Senior & Principal10 26%
  • Manager6 16%
See all 38 STERIS roles

More roles at STERIS

All 38 STERIS roles

Similar Quality Engineering roles elsewhere

Quality Engineer II at STERIS

Open until filled. $86K–$111K a year, employer provided.

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