New · posted Oct 15
STERIS · Medical Devices
Quality Analyst
- Saxonburg, PA
- On-site
- Full-time
- Associate & Specialist
Open until filled
The role
The Quality Analyst is responsible for assisting in administration of the quality management system at a site to assure adherence to ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137 and/or ISO 11135 and other applicable regulatory standards.This role leads complaint/CAPA investigations, supplier quality improvement initiatives, continuous improvement initiatives and countermeasures 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. The Analyst also supports production and quality operations by coordinating and performing problem-solving investigations, pre-reviews and final acceptance/run release of processing runs that contain non-conformances. Responsible for the activities related to quality and regulatory compliance to ensure all product processing requirements are met in accordance with Customer specifications including calibrations, dosimetry results, generation of test methods, audits, scheduling, validations, record keeping and reporting.
This role requires onsite work 5 days per week at our Saxonburg, PA facility. This role is not eligible for Visa Sponsorship or H1B Transfer.
Other
- Excellent problem-solving skills.
- Focus on identification of potential issues and continuous improvement.
- Experience working on cross-functional teams and on own initiative.
- Demonstrated excellent organizational, oral and written communications skills.
- Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.
- Ability to work in a fast-paced, regulated environment with strict deadlines.
- Mathematical skills including practical application of fractions, percentages, ratios, proportions and algebra.
What STERIS Offers
We value our employees and are committed to providing a comprehensive benefits package that support your health, well-being, and financial future.
What you need
Required
- Bachelor's Degree in Scientific or related technical field.
- 1-5 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
- 1-5 years of experience working in an ISO certified environment.
Preferrednice to have
- 1-5 years of experience with medical device or other regulated industries.
- Working knowledge of FDA QSR/ EUGMP regulations.
What you'll do
What You'll do as a Quality Analyst
- Coordinate day-to-day tasks and direction for Quality Technicians/Senior Quality Technicians by providing technical support, mentoring and oversight.
- Responsible for oversight of all product and/or report pre-reviews and releases conducted by Quality Technicians/Senior Quality Technicians.
- Responsible for executing product and/or report releases for all processing runs/lab samples containing a non-conformance, including management of Customer communication and leading the associated non-conformance investigations.
- Initiate and/or participate in corrective actions, problem-solving and continuous improvement activities.
- Perform internal audits at other AST facilities, including identification of non-compliances and report generation. Responsible for managing remediation of internal audit observations assigned by site Quality Manager.
- Manage creation of new quality system policies and procedures and revisions to existing policies/procedures.
- Review collected data to perform statistical analysis and recommend process 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.
- Lead quality system programs (i.e. calibration, maintenance, training, CAPA, complaints, non-conformances, supplier quality, management review, operational qualifications, document control, change control, risk management, etc).
- Overall responsibilities include commitment to ensure external and internal requirements ar met according to documented policies, procedures, standards and regulations.
- Perform other duties as assigned.
Pay and benefits
$75,000 – $90,000 a year
Employer providedPay range for this opportunity is $75,000 - $90,000. This position is eligible for bonus participation.
Here is just a brief overview of what we offer
Market Competitive Pay.
Extensive Paid Time Off (PTO) and 9 added Holidays.
Excellent Healthcare, Dental and vision benefits.
Long/Short Term Disability coverage.
401(k) with a company match.
Maternity & Paternity Leave.
Additional add-on benefits/discounts for programs such as Pet Insurance.
Tuition Reimbursement and continued educations programs.
Excellent opportunities for advancement in a stable long-term career.
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
Saxonburg, PAOn-siteOpen in Maps (opens in a new tab)
More jobs in Saxonburg, PAEqual opportunity, accessibility and legal noticesSTERIS's statements, word for word
STERIS does not accept unsolicited resumes/CV's from individual recruiters or third-party recruiting agencies in response to job postings.
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 5% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Associate & Specialist roles in Pennsylvania5 roles publishing pay
Associate & Specialist roles in the US157 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $75,000 | — | $90,000 |
| Pennsylvania (middle half) | $57,000 | $57,000 | $82,500 |
| 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 28 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs8
- Collaboration and leadership7
- Quality systems and risk6
- GMP and compliance4
- Investigations and CAPA3
- Lab testing and methods2
- Validation and qualification1
- 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 CommissionEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules and annexes
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
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 Analyst at STERIS
Open until filled. $75K–$90K a year, employer provided.