Sotera Health Company · 3 hours ago
VP Quality Assurance & Regulatory Affairs
2015 Spring Road, Oak Brook, IL, 60523-3909, US
Full-time
Onsite
Director/Executive
15+ years expSotera Health Company is a leading global provider of mission-critical sterilization and lab testing services for the healthcare industry. The Vice President of Quality Assurance is responsible for driving the company’s quality strategy, ensuring compliance with international standards and regulatory agencies, and leading a global team to foster a culture of continuous improvement.
BiotechnologyHealth CareMedical Device
Responsibilities
Ensure compliance with FDA, USDA, JPAL, ISO, and other global regulatory requirements
Serve as the company’s Management Representative for ISO and primary FDA correspondent
Oversee the Quality Management System, Internal Audit Program, and executive-level management reviews
Lead initiatives for continuous improvement and maintain plant DMF and MAF filings with the FDA
Represent Sterigenics with national and international standards groups (AAMI, ASQC, ASTM)
Partner with Operations, Sales, and Engineering to embed best practices, resolve customer issues, and support capital projects while ensuring regulatory compliance
Champion cross-functional collaboration to drive productivity and quality improvements
Engage with customers to communicate Sterigenics’ quality philosophy and address their needs
Develop and maintain service quality metrics and reporting systems to ensure consistent delivery and accountability
Develop and manage the QA organization’s budget, aligning with company financial goals
Contribute to fiscal objectives by integrating quality practices into operational performance
Recruit, develop, and retain top-quality assurance talent with potential for advancement
Enhance training programs to strengthen technical, leadership, and interpersonal skills
Contribute to performance evaluations of Quality Managers in partnership with site and operations leaders
Qualification
Required
Bachelor's degree in health sciences, engineering, or related technical discipline (advanced degree preferred)
15+ years of progressive leadership in quality assurance or engineering within the medical device or pharmaceutical industry
Expertise in global quality systems, FDA GMP compliance, process validation, and statistical quality tools
Proven success managing large, geographically diverse teams and complex global operations
Company
Sotera Health Company
Sotera Health brings together Sterigenics, Nelson Labs and Nordion, each of which are established, highly reputable players in the global health arena.
1001-5000 employees
H1B Sponsorship
Sotera Health Company 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 (1)
2024 (1)
Funding
Current Stage
Public CompanyTotal Funding
$3.3B2024-05-30Post Ipo Debt· $2.26B
2024-02-28Post Ipo Secondary· $368.75M
2021-03-17Post Ipo Secondary· $675M
Leadership Team
Alex Dimitrief
Senior Vice President and General Counsel
Kristin Gibbs
Chief Marketing Officer
Recent News
2026-01-07
2025-12-18
Company data provided by crunchbase