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New · posted Oct 17

STERIS · Medical Devices

Advanced Quality Engineer

  • Mentor, OH
  • On-site
  • Full-time
  • Senior & Principal
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Pay$108K–$139Ka year · employer provided
EmploymentFull-time
LocationMentor, OHOn-site
LevelSenior & Principal
FunctionQuality AssuranceQuality
Deadline

Open until filled

The role

The Advanced Quality Engineer in our Mentor, OH location has principal responsibility for managing highly complex projects involving the STERIS Quality Management System, service or manufacturing process quality improvements or technical product or service quality improvement.  These projects require significant cross-functional participation and support from all levels in STERIS. This role is tasked with leading, (1) acquisition or new site quality system integration, (2) acquisition or new site production and process control integration; (3) quality measurement system implementation; (4) business-wide quality system standardization; and (5) product, service and manufacturing quality technical analysis and improvement.

This role may also have responsibility for leading and executing the quality strategy for multiple manufacturing or service production lines.  The Advanced Quality Engineer is also 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.

A Bachelor's Degree in Engineering is required, plus a minimum of 8 years of related experience in manufacturing / quality systems, and a minimum of 8 years of experience working in an ISO certified environment.

This position requires working onsite in our Mentor, OH facility Monday through Friday. 

Requires potential travel up to 10 % for training or to visit supplier or other STERIS sites both domestically and internationally (Mexico). 

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, required.
  • Minimum of 8 years of related experience required. (Manufacturing/Quality Engineering and/or Quality Systems).
  • Minimum of 8 years of experience working in an ISO certified environment.
  • Experience with medical device or other regulated industries.
  • Quality Management System Regulation FDA (QMSR) Certification or familiarity with QMSR/GMP regulations.
  • Ability to travel up to 10% for training or to go to supplier or other STERIS sites both domestically and internationally (Mexico).

Preferrednice to have

  • ASQ Certification, preferred.
  • Project Management skills and experience.
  • Experience with design transfer, process harmonization and sustainability.
  • Knowledge of Track Wise, Windchill PLM, or other similar systems.
  • Knowledge of ISO 13485 regulations.

Skills named in this posting

What you'll do

What You’ll do as an Advanced Quality Engineer

  1. Leads the QMS integration of acquisitions or new manufacturing or service sites.
  2. Leads production and process control integration and improvement for acquisitions and new manufacturing or service sites.
  3. Leads Quality Management System design, implementation and improvement for new and existing manufacturing and service sites.
  4. Designs and implements quality measurement systems and improvements for new and existing manufacturing and service sites.
  5. Analyzes data and trends to ensure acceptance and effectiveness of site quality measurement systems.
  6. Leads business-wide Quality Management System standardization initiatives.
  7. Leads key manufacturing and service quality improvement initiatives and strategies.
  8. Leads and executes the quality strategy for multiple manufacturing or service production lines.
  9. Develops, implements, maintain and improves complex quality programs such as product and service quality, supplier controls and production/process controls.
  10. Develops and generate reports and analyses on quality improvement initiatives to present to senior management.
  11. Provides input to the annual Quality Planning Process.
  12. Instructs other STERIS employees in quality principles, such as quality systems, problem solving, and valid statistical techniques.
  13. Directs the work of Quality and other cross-functional staff in the execution of key projects and initiatives.
  14. Perform all other duties as assigned.

Pay and benefits

$107,525 – $139,150 a year

Employer provided
How this compares

Pay range for this opportunity is $107,525 - $139,150. 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.

Where you'll work

Mentor, OHOn-siteOpen in Maps (opens in a new tab)

More jobs in Mentor, OH
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.

Job intelligence

The context around this role

Live data · October 17, 2026

Salary intelligence

How the pay compares

This role's midpoint is level with the US median for Quality Assurance roles at this level.

This roleEmployer provided

$107,525 to $139,150 a year

Senior & Principal roles in the US281 roles publishing pay

Middle half $104,000 to $137,500, median $123,000
Annual base pay
Annual base payLowMedianHigh
This role$107,525—$139,150
All US$104,000$123,000$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 17, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Quality Assurance

The general path across 852 open Quality Assurance 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 · Quality Technician

    $80K median230 open

  2. This role

    Senior & Principal

    Often: Quality Engineer · Senior Quality Engineer

    $123K median354 open

  3. Next step

    Manager

    Often: Manager, Quality Assurance · Quality Manager

    $155K median136 open

  4. Later

    Director

    Often: Director, Quality · Associate Director, Quality Assurance

    $209K median116 open

  5. Later

    VP & Executive

    Often: Vice President, Quality Assurance · AVP

    $306K median16 open

Career resources on Quality Assurance

Skills DNA

What this role leans on

How many of the posting's 39 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 3 linesDocumentation and SOPs: 2 linesRegulatory submissions: 1 lineQuality systems and risk: 13 linesCollaboration and leadership: 14 linesGMPDocumentationSubmissionsQuality systemsTeamwork
  • Collaboration and leadership14
  • Quality systems and risk13
  • GMP and compliance3
  • Documentation and SOPs2
  • 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.

From Regulatory News

Manufacturing and quality coverage for this profession

Company hiring pulse

STERIS on Regulatory Jobs

32
Open roles
22
Distinct roles
14
Locations

By discipline

  • Quality29 91%
  • Regulatory3 9%

By level

  • Associate & Specialist18 56%
  • Senior & Principal8 25%
  • Manager5 16%
See all 32 STERIS roles

More roles at STERIS

All 32 STERIS roles

Similar Quality Assurance roles elsewhere

Advanced Quality Engineer at STERIS

Open until filled. $108K–$139K a year, employer provided.

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