New · posted Oct 15
STERIS · Medical Devices
Quality Engineer II
- Mentor, OH
- On-site
- Full-time
- Senior & Principal
Open until filled
The role
The Quality Engineer II our Mentor, OH 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 working onsite in our Mentor, OH location on a four 9- hour days and a 4-hour day schedule to support production.
You can work either Monday to Thursday 7:00 am to 4:30pm, and Fridays 7:00am 11:00am Or Monday to Thursday 8:00am to 5:30 and Fridays 8:30 am to 12:00 pm.
Other
- Excellent problem-solving skills
- Has a continuous improvement mindset embracing new ideas and ways to think about a project.
- Maintains strong relationships cross functionally to solve problems collaboratively.
- Communicates through facts and data.
- Demonstrates the technical aspects of the role.
- Applies new technical tools and concepts under the direction of others.
- Invests in growth through formal training or stretch project.
- Completes assigned tasks on time by following standard work processes.
- Thrives on change and adapts to leader-initiated changes.
- Participates in change initiatives to better understand business and project goals.
What you need
Required
- Bachelors’ degree in Engineering
- Minimum 3 years’ combined Manufacturing/Quality Engineering and/or Quality Systems experience.
- Minimum 3 years’ experience working in an ISO certified environment required.
Preferrednice to have
- Experience with medical device or other regulated industries preferred.
- ASQ- Certified Quality Auditor and/or Quality Engineer, QMSR or familiarity with QMSR/GMP regulations preferred.
- Proficiency with MS Office applications such as Excel, Word, PowerPoint.
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, designed 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
$79,688 – $98,438 a year
Employer providedWhat STERIS Offers
We value our employees and are committed to providing a comprehensive benefits package that supports your health, wellbeing, and financial future.
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
Pay range for this opportunity is $79,687.50 - $98,437.50.50. This position is eligible for bonus participation.
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.
Market competitive pay
Paid time off and holidays
Healthcare, dental and vision
Short- and long-term disability
401(k) with company match
Tuition reimbursement
Where you'll work
Mentor, OHOn-siteOpen in Maps (opens in a new tab)
More jobs in Mentor, OHEqual 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 27% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in the US284 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $79,688 | — | $98,438 |
| 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 30 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership8
- Quality systems and risk5
- GMP and compliance4
- Documentation and SOPs2
- Investigations and CAPA2
- Regulatory submissions1
- Data and digital systems1
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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Quality Engineer II at STERIS
Open until filled. $80K–$98K a year, employer provided.