New · posted Oct 31
STERIS · Medical Devices
Manager, Quality Systems
- Cooper City, FL
- On-site
- Full-time
- Manager
The role
The Quality Manager in our Cooper City, FL (Fort Lauderdale) facility is responsible for leading quality improvement for a manufacturing or service facility/function. This position leads implementing and maintaining state-of-the-art quality practices for associated product and service lines. The Quality Manager assumes overall responsibility in ensuring that the site maintains operational and quality systems in a state of compliance to domestic and international standards. The role is responsible for the organization, documentation and maintenance of the quality system to be compliant with, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP and CFR Part 820/211, EU MDR and other applicable standards. This role leads the local site efforts focused on product/service quality improvement, supplier quality, process quality, new product/service development quality and quality system compliance. The Quality Manager serves as the Management Representative for the site(s) and is responsible for ensuring the quality system meets all applicable regulatory standards.
This position requires working onsite in our Cooper City, FL (Fort Lauderdale) location during core business hours. Domestic travel up to 10- 20% is required.
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.
- Experience with statistical analysis software and Visio preferred.
What STERIS 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 or related field.
- Minium of 8 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
- Minimum of 8 years of experience working in an ISO certified environment required.
- Minimum of 2 years in a Quality leadership role.
- Must fulfil the experience requirements listed in Article 15 of the EUMDR (PRRC).
- Ability to travel 10 - 20% domestically, required.
Preferrednice to have
- Minimum of 8years of experience with medical device or other regulated industries preferred.
- ASQ, QSR Certification or familiarity with QSR/GMP regulations preferred.
What you'll do
What You'll do as a Quality Manager
- Lead the organization’s Quality staff to ensure compliance to the overall Quality Management System and drive continuous improvement.
- Lead the organization’s Quality staff to ensure alignment to manufacturing and servicing operations, support Lean efforts and drive quality improvement for products and services.
- Work closely with site senior management to provide strategic direction and development of the organization’s quality strategies and tactics.
- Provide quality viewpoints and opinions on future product and service development.
- Provide coaching, mentoring and leadership to the Quality staff.
- Serve as the site’s Management Representative and lead the organization’s Management Review process.
- Ensure compliance with appropriate domestic regulatory and international standards and requirements.
- Lead the organization's continuous improvement process, including data analysis, improvement projects and process capability to improve key metrics as measured by the product/service quality dashboard.
- Lead and implement effective production and process controls.
- Manage the complaint handling processes to insure customer responsiveness and product and process improvements.
- Ensure compliance to the New Product Development process and assurance that the Product Requirements Document includes key quality performance metrics.
- Assess new designs for manufacturability, testability and reliability to ensure the Quality risks and deliverables of the New Product Development process meet the required application reliability and design intent.
- Determine supplier qualification risks based upon criticality of component and supplier process capability.
- The position requires a level of authority to conduct and direct required activities such as quality planning, personnel management and regulatory compliance.
- This individual has autonomy to perform the duties of Person Responsible for Regulatory Compliance (PRRC) on behalf of STERIS legal manufacturing entities under the EU MDR. This individual shall suffer no disadvantage within the organization in relation to proper fulfilment of his or her duties in lieu of article 15 of the EU MDR.
- Perform other duties as assigned.
Pay and benefits
$107,525 a year
Employer providedPay range for this opportunity is $107,525.00 to 139,150.00. 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
Where you'll work
Cooper City, FLOn-siteOpen in Maps (opens in a new tab)
More jobs in Cooper City, FLEqual opportunity, accessibility and legal noticesSTERIS's statements, word for word
STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity and the use of affirmative action programs 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 31, 2026
Salary intelligence
How the pay compares
This role's midpoint is 28% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Manager roles in the US119 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $107,525 | — | $107,525 |
| All US (middle half) | $126,750 | $149,000 | $166,000 |
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 31, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 974 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 33 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership10
- Quality systems and risk8
- GMP and compliance7
- Documentation and SOPs2
- Regulatory submissions2
- Data and digital systems2
- Lab testing and methods1
- Investigations and CAPA1
- Validation and qualification1
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
- 36
- Open roles
- 25
- Distinct roles
- 16
- Locations
By discipline
- Quality33 92%
- Regulatory3 8%
By level
- Associate & Specialist20 56%
- Senior & Principal9 25%
- Manager6 17%
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Manager, Quality Systems at STERIS
Open until filled. $108K a year, employer provided.