New · posted Oct 15
STERIS · Medical Devices
Advanced Quality Engineer
- St. Louis, MO
- On-site
- Full-time
- Senior & Principal
Open until filled
The role
The Advanced Quality Engineer has principal responsibility for managing highly complex projects involving the STERIS Quality Management System, service or manufacturing process quality improvements or technical product or service quality improvement. These projects require significant cross-functional participation and support from all levels in STERIS.
This role is tasked with leading
- acquisition or new site quality system integration
- acquisition or new site production and process control integration
- quality measurement system implementation
- business-wide quality system standardization
- product, service and manufacturing quality technical analysis and improvement.
This role may also have responsibility for leading and executing the quality strategy for multiple manufacturing or service production lines. The Advanced Quality Engineer is also responsible for managing processes and leading projects to maintain and improve the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP and FDA 21 CFR Part 820/211, EU MDR and other applicable standards.
This position may require up to 10% Travel domestically.
What you need
The Experience, Skills, and Abilities Needed
Required
- Bachelor's Degree in Engineering.
- Minimum of 8 years of related experience required. (Manufacturing/Quality Engineering and/or Quality Systems)
- 8+ years of experience working in an ISO certified environment
Preferred
- Experience with medical device or other regulated industries.
- ASQ, QSR or familiarity with QSR/GMP regulations
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.
STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services around the globe. For more information, visit www.steris.com.
If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.
What you'll do
What You'll do as an Advanced Quality Engineer
- Leads the QMS integration of acquisitions or new manufacturing or service sites.
- Leads production and process control integration and improvement for acquisitions and new manufacturing or service sites.
- Leads Quality Management System design, implementation and improvement for new and existing manufacturing and service sites.
- Designs and implements quality measurement systems and improvements for new and existing manufacturing and service sites.
- Analyzes data and trends to ensure acceptance and effectiveness of site quality measurement systems.
- Leads business-wide Quality Management System standardization initiatives.
- Leads key manufacturing and service quality improvement initiatives and strategies.
- Leads and executes the quality strategy for multiple manufacturing or service production lines.
- Develops, implements, maintain and improves complex quality programs such as product and service quality, supplier controls and production/process controls.
- Develops and generate reports and analyses on quality improvement initiatives to present to senior management.
- Provides input to the annual Quality Planning Process.
- Instructs other STERIS employees in quality principles, such as quality systems, problem solving, and valid statistical techniques.
- Directs the work of Quality and other cross-functional staff in the execution of key projects and initiatives.
- Manages complex and ambiguous problems and formulates technical solutions.
- Provides team members and leadership with feedback and support on technical issues.
- Identifies and develops new technical ideas.
- Identifies risks and communicates effective mitigation strategies.
- Challenges existing processes and proactively seeks creative solutions to enhance performance.
- Gathers complex information from various sources and simplifies designs and procedures for better understanding.
- Leads a team to brainstorm solutions for routine technical issues, involving key individuals in the decision-making process.
- Makes effective decisions by considering cost, efficiency, and customer needs, even when data is limited.
- Designs adaptable solutions that align with broader strategic goals and respond to changes in technology and clinical use.
- Incorporates industry knowledge into technical solutions and influences the team’s design and product development strategies.
- Fosters strong relationships with partners by promoting trust, considering input, and resolving issues collaboratively to ensure future partnerships.
- Coordinates strategies and resources across departments to maintain consistent communication and support organizational goals.
- Utilizes a collaborative style to negotiate win-win outcomes, effectively conveying complex information through visuals and listening to technical concerns.
- Anticipates customer needs and proactively provides solutions, developing tools that enhance project continuity and efficiency.
Pay and benefits
$107,525 – $139,150 a year
Employer providedPay range for this opportunity is $107,525.00 - $139,150.00. This position is eligible for bonus participation.
Bonus eligibility
Comprehensive benefits portfolio
Where you'll work
St. Louis, MOOn-siteOpen in Maps (opens in a new tab)
More jobs in St. Louis, MOEqual 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.
The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is level with the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in the US284 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $107,525 | — | $139,150 |
| 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 48 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership15
- Quality systems and risk10
- GMP and compliance2
- Documentation and SOPs2
- 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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Advanced Quality Engineer at STERIS
Open until filled. $108K–$139K a year, employer provided.