Senior Quality Specialist
STERIS · Mentor, OH
- Level
- Senior
- Team
- Quality
- Base pay
- $69k–$85k
- Degree
- Required
- Industry
- Medical devices
- Posted
- 16 days ago
The role in 30 seconds
A senior quality role at STERIS (medical devices) in Mentor, OH. Track, trend and analyze Quality data.
- They ask for
- degree required
- Tools it names
- Lean, Root cause, CAPA, ISO 9001, ISO 13485, FDA / GMP
- Base pay
- $69k–$85k
- Day to day
- some off-shift / weekend coverage
Read from the posting. The full description is below.
From the plant jobs report · week of November 2, 2026
Quality Engineer roles in Ohio: typical posted base $90k–$130k. This one lists $69k–$85k.
Median of the low and high ends of 7 live postings that list pay, out of 63 quality engineer openings in Ohio, read from manufacturers' own careers sites.
Ohio plant jobs report →Pay by team and state →What moves pay →
How this role compares
Against 62 other live quality postings in Ohio.
- Base pay
- About 30% below similar roles
- Experience asked
- Not stated
Typical $90k–$130k, from 5 postings that list pay.
Similar roles usually ask 5+ years.
Skills these teams ask for most
- ✓ Root cause 62%
- PPAP 48%
- ✓ ISO 9001 46%
- ✓ Supplier quality 43%
- FMEA 41%
- APQP 37%
✓ = this posting asks for it too. % = share of similar postings that mention it.
Stands out: this posting asks for CAPA, FDA / GMP, which few similar roles mention. If you have it, lead with it.
At a glance
Pulled from the posting text. If it's not listed here, the posting didn't say.
How to get in at this plant
Five moves over a week or two. The first one takes ten minutes.
- 1
Pick 2–3 people on the Quality team at STERIS
We found 2 people at this company and state: 1 in this kind of role, 1 leaders. Engineers who joined in the last year or two reply the most. See them ↓
- 2
Send a short, curious note
One real question about their work. No favors yet. Each person gets a different note, written for this role.
Write to West → (free) - 3
Turn a reply into a short call
Questions worth asking about this team:
- What does a normal week look like on your team?
- Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
- How much of the job is customer complaints versus prevention?
- How does off-shift and weekend coverage work?
- How did you land the job? What stood out in your interviews?
- 4
Apply with someone vouching for you
If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.
- 5
Bring proof to the interview
One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.
This plant: STERIS in Mentor
12 other open roles at this site · 2 people we found in quality roles at STERIS.
- Director, Continuous Improvement · Lean / CI · Director+
- Senior Process Manufacturing Engineer (NPI) · Process · Senior
- Advanced Quality Engineer · Quality
- Director, Quality (Mentor, OH or Plymouth, MN onsite based) · Quality · Director+
- Director, Facilities Maintenance and Asset Management · Reliability · Director+
- Quality Engineer II · Quality
Full description from STERISAs posted on their careers site.ShowHide
Position Summary
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'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.
Show full description ↓Show less ↑
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.
Preferred
- +ASQ, QSR, or AAMI certification
What 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.