New · posted Oct 15
STERIS · Medical Devices
Quality Engineer II
- Conroe, TX
- On-site
- Full-time
- Senior & Principal
Open until filled
The role
The Quality Engineer II in our Conroe, TX 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 Conroe, TX location between the hours of 7:30am to 4:00pm or 8am to 5pm.
What STERI 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.
- Minimum of 3 years of related experience (Manufacturing/Quality Engineering and/or Quality Systems), required.
- Minimum of 3 years of experience working in an ISO certified environment.
- Ability to travel domestically 10 %- 20%.
Preferrednice to have
- ASQ, QSR Certification or familiarity with QSR/GMP regulations preferred.
- Experience with statistical analysis software and Visio, preferred.
- Knowledge of medical device industry standards ISO 13485 and FDA 21 CFR Part 820/211 preferred.
- QMS software (such as TrackWise or other QMS software system), SAP or Oracle experience, preferred.
What you'll do
What You’ll do as a Quality Engineer II
- Participate in cross-functional new product development teams with focus on product/ service quality and Quality System compliance.
- Develop and implement statistically valid sampling plans, design 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 supplier audits and quality system audits; provide guidance on corrective actions.
- Perform other duties as assigned
Pay and benefits
$90,000 – $105,000 a year
Employer providedPay range for this opportunity is $90,000 - $105,000. 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
Conroe, TXOn-siteOpen in Maps (opens in a new tab)
More jobs in Conroe, TXEqual 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 21% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in Texas6 roles publishing pay
Senior & Principal roles in the US284 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $90,000 | — | $105,000 |
| Texas (middle half) | $90,375 | $100,250 | $123,250 |
| 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 22 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk6
- GMP and compliance5
- Documentation and SOPs2
- Investigations and CAPA2
- Data and digital systems2
- Collaboration and leadership2
- 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 Engineer II at STERIS
Open until filled. $90K–$105K a year, employer provided.