New · posted Oct 20
STERIS · Medical Devices
Senior Quality Specialist
- Mentor, OH
- On-site
- Full-time
- Senior & Principal
Open until filled
The role
The Senior Quality Specialist 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 manages document control transactions, site record retention, calibration and inspection activities. In addition, the Senior Quality Specialist will lead Customer complaints, CAPA and NCR investigations, manage site audit activities, support supplier quality and customer assessments and lead risk management activities where appropriate. This role may also track and trend Quality data and support a site’s Management Review process.
What you need
Reqiured
Bachelor’s degree required in related technical field (i.e. Engineering, Chemistry, Biology).
Minimum five (5) years of experience in a regulated industry (i.e. FDA/ISO 13485)
Knowledge of standard quality analysis tools (Problem Solving/Root Cause Analysis)
• 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.
• Job Knowledge: PC experience and working familiarity of common desktop applications including Excel and Word.
• Initiative/Leadership: Takes ownership of task and projects and seeks clarification if unsure of direction.
• Understands and can interpret appropriate regulatory standards.
• Ability to analyze and interpret data and use as input to problem solving.
Preferrednice to have
- ASQ, QSR, or AAMI certification
What you'll do
What You'll Do as a Senior Quality Systems Specialist
• Manage the document control processes for the site.
• Lead Customer complaint investigations and ensure complete complaint documentation.
• Lead CAPA and NCR investigations and ensure proper documentation.
• Manage the DHR and batch record release process.
• Manage record retention practices within the site.
• Coordinate site calibration activities and recordkeeping.
• Manage site audit activities and recordkeeping.
• Support supplier quality and Customer assessment activities.
• Track, trend and analyze Quality data.
• Support targeted Lean activities.
• Complete other duties as assigned.
Pay and benefits
$68,600 – $84,780 a year
Employer providedWhat STERIS Offers
We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future.
Here is a brief overview of what we offer:
• Market Competitive Pay
• Extensive Paid Time Off and (9) added Holidays
• Excellent Healthcare, Dental and Vision Benefits
• Long/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 continued education programs
• Excellent opportunities for advancement in a stable long-term career
Pay range for this opportunity is $68,600 - $84,780. 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.
Paid time off and 9 added holidays
Healthcare, dental and vision
Short/long term disability coverage
401(k) with company match
Maternity and paternity leave
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.
Job intelligence
The context around this role
Live data · October 20, 2026
Salary intelligence
How the pay compares
This role's midpoint is 36% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in Ohio5 roles publishing pay
Senior & Principal roles in the US302 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $68,600 | — | $84,780 |
| Ohio (middle half) | $80,000 | $81,000 | $92,500 |
| All US (middle half) | $102,625 | $120,250 | $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 20, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 895 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 6 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk4
- Collaboration and leadership4
- Investigations and CAPA3
- GMP and compliance2
- Documentation and SOPs2
- 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
- 33
- Open roles
- 23
- Distinct roles
- 14
- Locations
By discipline
- Quality30 91%
- Regulatory3 9%
By level
- Associate & Specialist18 55%
- Senior & Principal9 27%
- Manager5 15%
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Senior Quality Specialist at STERIS
Open until filled. $69K–$85K a year, employer provided.