STERIS · 21 hours ago
Manager, Quality Systems
North Grafton, MA
Full-time
Onsite
Senior Level, Lead/Staff
$114K/yr - $147K/yr
10+ years expSTERIS is a company that helps create a healthier and safer world by providing innovative healthcare and life science product and service solutions. The Quality Manager is responsible for leading quality improvement efforts at an AST processing or lab facility, ensuring compliance with domestic and international standards while managing the quality systems and 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 operations, support Lean efforts and drive quality improvement for services/processes
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 service/technology offerings
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 CAPA, complaint and non-conformance handling processes to insure customer responsiveness and process improvements
Responsible for successfully leading and managing Regulatory Agency and Notified Body inspections and driving the creation and implementation of sustainable and effective remediation plans. Responsible for overseeing completion of Customer audits. Apply regulatory knowledge and judgment to the evaluation of quality concerns and regulatory compliance issues
Travel to other AST facilities, domestically and/or globally, to support remediation activities, audits/inspections and/or continuous improvement initiatives
Overall responsibilities include commitment to ensure external and internal requirements are met according to documented policies, procedures, standards and regulations
The position requires a level of authority to conduct and direct required activities such as quality planning, personnel management and regulatory compliance
Perform other duties as assigned
Qualification
Required
A bachelor's degree in engineering or related technical field
10 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience
10 years of experience working in an ISO certified environment required
Minimum of 2 years in a Quality leadership role
The role is responsible for the organization, documentation and maintenance of the quality system to be compliant with, as appropriate, the following standards: 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
Preferred
10 years of experience with medical device or other regulated industries preferred
Sterilization experience preferred
Working knowledge of FDA QSR/ EUGMP regulations strongly preferred
Benefits
Competitive base salary plus bonus (as applicable)
Comprehensive benefits package that includes medical, dental, vision, paid PTO and holidays
401K with company match
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
GlobeNewswire
2026-01-22
2025-11-05
Company data provided by crunchbase