New · posted Oct 15
STERIS · Medical Devices
Quality Systems Specialist
- Mentor, OH
- On-site
- Full-time
- Associate & Specialist
Open until filled
The role
The Quality Specialist in our Mentor, OH location is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This role coordinates document control transactions, site record retention, calibration and inspection activities. In addition, the Quality Specialist will facilitate Customer complaint investigations, assist in audit coordination, support supplier quality and customer assessments and support risk management activities where appropriate. This role may also track and trend Quality data and support the site Management Review process.
This role requires working onsite in our Mentor, OH location Monday through Friday.
Other
- Customer Focused: Demonstrates a “Customer first” mindset. Responds with a sense of urgency.
- Teamwork: Collaborates with others. Works in a professional manner to support team actions.
- Results: Effectively manages work tasks. Is detail oriented and strives for continuous improvement. Ability to analyze technical issues. Ability to cope with change and shifting priorities.
- Communication: Constructs clear written communication. Keeps manager and co-workers informed.
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
- Associates degree and a minimum of 2 years of experience in Quality in a regulated industry (i.e. FDA/ISO 13485).
- In lieu of a degree, a high school diploma or GED and 6 years of experience in a regulated industry.
Preferrednice to have
- Experience working in a manufacturing environment, preferred.
- Previous Quality Specialist experience and a strong understanding of Quality Management Systems.
- Strong interpersonal communication and collaboration skills (will work with training program).
- Experience working with applications such as Trackwise or Windchill.
- Knowledge of MS Office Suite applications including Excel and PowerPoint.
What you'll do
What You’ll do as a Quality Specialist
- Complete document control transactions.
- Manage Customer complaint investigations and complete complaint documentation.
- Facilitate CAPA and NCR investigations and may coordinate investigation documentation.
- Review DHR’s and support batch record release.
- Manage record retention practices within the site.
- Manage site calibration activities and recordkeeping.
- Support site inspection activities and recordkeeping.
- Coordinate internal and external audits.
- Support supplier quality and Customer assessment activities.
- Track and trend site Quality data.
- Support targeted Lean activities.
- Complete other duties as assigned.
Pay and benefits
$59,075 – $76,450 a year
Employer providedPay range for this opportunity is $59,075 - $76,450. 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, 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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 14% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Associate & Specialist roles in Ohio6 roles publishing pay
Associate & Specialist roles in the US157 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $59,075 | — | $76,450 |
| Ohio (middle half) | $53,000 | $66,250 | $79,500 |
| All US (middle half) | $59,000 | $78,500 | $94,000 |
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 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs6
- Quality systems and risk5
- Collaboration and leadership5
- GMP and compliance3
- Investigations and CAPA3
- Data and digital systems2
- 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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Quality Systems Specialist at STERIS
Open until filled. $59K–$76K a year, employer provided.