Join a leading EO (Ethylene Oxide) sterilisation plant dedicated to providing safe, effective, and high-quality sterilisation solutions. We are committed to ensuring our processes meet the highest industry standards, ensuring the safety and reliability of medical devices and other critical products.
We are seeking a Quality Manager to lead our Quality Assurance and Control teams. As the Quality Manager, you will play a pivotal role in ensuring our sterilisation processes comply with regulatory standards. You will also drive continuous improvement initiatives and foster a culture of quality throughout the organisation. You will maintain the Quality Management System (QMS) within the Somercotes Facility.
Responsibilities
Key Responsibilities:
* Is the nominated Facility Management Representative with respect to ISO9001/13485/ 21 CFR Pt820
* Lead and manage the quality department, overseeing all quality assurance and control activities.
* Develop and implement quality management systems (QMS) and procedures to maintain best practices.
* Conduct regular audits (internal and external) and manage customer audits and regulatory inspections.
* Oversee root cause analysis, CAPA processes, and quality-related investigations.
* Collaborate with production, R&D, and regulatory teams to ensure all products and processes meet stringent quality standards.
* Lead continuous improvement initiatives aimed at optimising quality processes and reducing risk.
* Provide training and guidance to staff on quality principles and regulatory requirements.
* The QA Manager has responsibility for the QA Technicians and Validation coordinators within the Somercotes facility.
Qualifications
Qualifications & Experience:
* Proven experience as a Quality Manager, ideally within EO sterilisation or a regulated manufacturing environment.
* In-depth knowledge of relevant standards.
* Strong background in managing quality systems, audits, and regulatory compliance.
* Excellent leadership and communication skills, with the ability to influence across departments.
* Degree in a relevant scientific or engineering discipline is desirable.
Job Info
* Job Identification 12744
* Job Category Quality Assurance/Quality Control
* Posting Date 11/19/2024, 09:39 AM
* Job Schedule Full time
About Us
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.
About the Team
Sterigenics is a leading global provider of outsourced terminal sterilization services for the medical device, pharmaceutical, food safety and advanced applications markets. With our industry recognized expertise we help to ensure the safety of millions of patients around the world every year. Across our 48 global facilities, we offer our customers a complete range of sterilization services, primarily using the three major technologies: gamma irradiation, ethylene oxide processing and electron beam irradiation. We are committed to addressing the growing need for sterilization across the world and partnering with our customers to eliminate threats to human health.
Safeguarding Global Health - with every product we sterilize.
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