Responsibilities/Duties Quality Assurance • In close collaboration with the Quality Manager: o Implement continual improvement attitude. o Review the facilities quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. o Maintain the contacts with supplier/customer (visits, meetings, complaint handling, audits …). o Ensure the required systems are operative and effective to assure customers of the desired quality. o Lead projects and programs to achieve and improve facility targets and objectives. • Keep quality indicators up to date (TQMR) • Perform internal audits. • Review and approve validation protocols and reports • Review various records ( calibration reports, maintenance planning …) Quality Control • Assure smooth daily operations in Quality technician team • Assure training and administrative follow up of QC technicians. • Develop team spirit and a culture in line with the corporate values • Assure internal and external follow-up in case of process deficiency (non-conformance, deviation). • Coordinate and implement corrective and preventive actions. • Assure validation instructions are well understood by process QC technicians • Assure customer’s documentation is well respected within the organization Authority: • The QA Supervisor reports to the local Quality Manager Requirements: Knowledge/Education and Training: • Industrial Engineer or equivalent • Modern Quality Systems & standards • ISO, FDA Experience: • Relevant experience in quality matters (familiar with Quality tools, lean management ) • Experience in the pharmaceutical medical device industry or automotive industry is an advantage. • Fluent in English and French (reading, speaking, writing). Skills: • Fine organisational skills • Efficient, accurate, work according to plan • Problem solving attitude • High profile commitment to quality
Contacts: Internal: • Quality Manager and all departments within the local organization External: • Suppliers, Customers
Deputy: • Quality Manager
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.
Report job
