Sterigenics · 7 hours ago
VP Quality Assurance & Regulatory Affairs
Oak Brook, IL
Full-time
Onsite
Director/Executive
15+ years expSterigenics is a leading global provider of sterilization and lab testing services for the healthcare industry. The Vice President of Quality Assurance will oversee global quality systems and regulatory compliance, drive quality strategy, and lead a team to ensure adherence to international standards while fostering a culture of continuous improvement.
Health CareMedicalMedical DevicePharmaceuticalProduct ResearchTechnical Support
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
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
Collaborative, hands-on leader who inspires confidence and credibility at all levels
Strong communicator with the ability to influence and negotiate across functions and cultures
Integrity, professionalism, and a reputation for high ethical standards
Innovative problem-solver with the ability to simplify and execute complex ideas
Global mindset and sensitivity to diverse cultures and work environments
Preferred
Advanced degree
Company
Sterigenics
Sterigenics, a Sotera Health company, is a global leader in comprehensive sterilization services for the medical device, pharmaceutical, food safety and advanced applications markets.
1001-5000 employees
H1B Sponsorship
Sterigenics 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
$307M2025-09-03Post Ipo Secondary· $307M
2020-11-20IPO
2011-03-23Acquired
Leadership Team
Kamila Sarraf
Human Resources Business Partner
Recent News
Chicago Tribune
2024-04-08
Company data provided by crunchbase