We are looking for a Quality Assurance Manager to join our team at the Markham Vale facility. This is a key leadership role responsible for maintaining our Quality Management System (QMS) and driving Total Quality Management (TQM) within the facility.,

• Act as the Facility Management Representative for ISO9001/13485/21 CFR Pt820 compliance and Responsible Engineering Manager under Japanese Pharmaceutical Affairs Law.
• Develop and communicate the quality policy, ensuring alignment with company objectives.
• Lead quality improvement initiatives and oversee performance monitoring to enhance customer satisfaction.
• Manage internal and external audits, including ISO, GMP, FDA, and customer audits.
• Ensure all QMS processes are effectively implemented, maintained, and improved.
• Provide leadership, training and development for the quality assurance team members.
• Oversee corrective and preventive actions (CAPA) and drive continuous improvement in quality standards.
• Represent the company in quality-related supplier and customer interactions., This role offers a fantastic opportunity to lead quality initiatives in a dynamic and highly regulated environment. You will play a crucial part in ensuring compliance, driving improvements, and fostering a culture of quality excellence across the facility.
  
  Academic degree or equivalent experience.
• Strong knowledge of Quality Systems and Standards (ISO, FDA, MHRA regulations).
• Minimum 3 years of leadership experience in quality assurance.
• Experience in the pharmaceutical or medical device industry is an advantage.
• Proven ability to conduct quality audits and manage regulatory compliance.
• Strong organizational, communication, and problem-solving skills.
• Flexible approach to work, including occasional travel locally/abroad and out of hours site visits.
• Passion for continuous improvement and a commitment to maintaining the highest quality standards.
  
  The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company's unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year. Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 8 of the top 10 global pharmaceutical companies.
Sotera Health goes to market through its three best-in-class businesses - Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Learn more about Sotera Health at soterahealth.com.