STERIS · 16 hours ago
Manager, Quality
Mentor, OH
Full-time
Onsite
Senior Level, Lead/Staff
$105K/yr - $136K/yr
8+ years expSTERIS is a company dedicated to creating a healthier and safer world through innovative healthcare and life science solutions. The Quality Manager is responsible for leading quality improvement efforts within a manufacturing or service facility, ensuring compliance with various international standards, and overseeing the quality management system. This role involves strategic direction, continuous improvement initiatives, and management of the organization's quality staff.
BiotechnologyHealth CareMedical Device
Responsibilities
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
Qualification
Required
Bachelor's Degree (Engineering or related technical field)
Minimum 8 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience
Minimum 8 years of experience working in an ISO certified environment
Minimum of 2 years in a Quality leadership role
Must fulfil the experience requirements listed in Article 15 of the EUMDR (PRRC)
Preferred
Minimum 8 years of experience with medical device or other regulated industries
ASQ, QSR or familiarity with QSR/GMP regulations
Experience with statistical analysis software and Visio
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
Benefits
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 company match
Maternity and parental leave
Additional add on benefits/discounts for programs such as pet insurance
Tuition reimbursement and continued educational programs
Excellent opportunities for advancement in a stable long-term career
Company
STERIS
STERIS is a leading provider of infection prevention and other procedural products and services, focused primarily on healthcare, pharmaceutical and medical device Customers.
10001+ employees
H1B Sponsorship
STERIS has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (26)
2024 (28)
2023 (15)
2022 (33)
2021 (18)
2020 (19)
Funding
Current Stage
Public CompanyTotal Funding
$0.28M2010-05-21Post Ipo Debt· $0.28M
1998-12-01IPO
Leadership Team
Daniel Carestio
President and CEO, STERIS
Walter Rosebrough
CEO Emeritus & Senior Advisor
Recent News
2025-11-05
Company data provided by crunchbase