STERIS · 2 days ago
Lead, Quality & Regulatory Compliance Auditor
Mentor, OH
Full-time
Hybrid
Mid, Senior Level
$78K/yr - $95K/yr
4+ years expSTERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. The Lead, Quality & Regulatory Compliance Auditor will oversee internal quality audits and ensure compliance with regulations and standards while training new auditors and supporting quality operations.
BiotechnologyHealth CareMedical Device
Hiring Manager
Stephanie Arnold, SHRM-CP, SHRM-TA
Responsibilities
Lead internal quality audits to assess compliance of a facility’s quality management system with applicable US and international standards, regulatory requirements, and Corporate and local procedures, policies, and work instructions. Conduct internal audits using good time management practices to maximize efficiency
Draft internal audit reports to clearly communicate audit findings and recommendations for compliance improvements
Address and resolve any differences in viewpoints in a positive manner with a focus on continuous improvement and business efficiency while maintaining compliance
Train developing auditors to support the internal quality auditing activity
Support execution of the supplier quality audit program, including, qualifications and/or audits, routine monitoring, assessment meetings, action requests, and as necessary, issue resolution
Provide support to the Quality & Regulatory Compliance team in the investigation and resolution of audit observations
Review corrective action activities for audit observations and obtain and review objective evidence as actions are completed in accordance with prescribed commitments
Lead and support the Quality Operations team in supporting key objectives, trending, and process improvement
Qualification
Required
Four (4) year degree required, preferably with general business core, risk management, project management, regulatory, or internal audit
Minimum of four (4) years professional experience, preferably including regulatory affairs, legal, governmental compliance, quality systems, or internal auditing
25% travel required (domestic & international)
Demonstrated experience in effectively leading quality audits
Demonstrated ability to balance multiple high priority responsibilities on-time and effectively
Self-starter with demonstrated organizational, project management, time management, and problem-solving skills
Can comfortably and effectively confront difficult situations and issues in a timely and appropriate manner
Strong interpersonal skills – ability to work closely with people at all levels within the STERIS organization and facilitate the implementation of corrective actions; able to work effectively and professionally with external people including suppliers
Strong oral and written communication skills
Excellent PC skills, including Microsoft Office applications, and the use of AI tools
Expert working knowledge of the following regulations and standards: 21 CFR Part 820, 21 CFR Part 803, 21 CFR Part 806, 21 CFR Part 7, 21 CFR Part 211, 21 CFR Part 11, ISO 13485, ISO 9001, EN ISO 11135-1, EN ISO 11137-1, ISO/IEC 17025, ISO 14971, EU Medical Device Directive, EU Medical Device Regulation
Preferred
Leadership / people management experience preferred
Experience in the medical device industry is a plus
Professional certifications and regulatory training certificates in relevant disciplines are desirable, as is completion of or actively working towards an advanced degree in a relevant discipline
Bilingual skills are a plus, but not required
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 a company match
Maternity and Paternity Leave
Additional add-on benefits/discounts for programs such as Pet Insurance
Tuition Reimbursement and continued education programs
Excellent opportunities for advancement in a stable long-term care
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