Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care.
We provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs.
At Convatec, we're transforming our business for the better. Better products. Better ways of working. And better ways of delivering for our customers and each other. We're aiming for nothing short of excellence.
About the Role
The Microbiology and Environmental Compliance Manager will lead sterilization and microbiological initiatives, ensuring compliance with quality requirements and regulatory standards. This role involves coordinating cross-functional teams, developing policies and procedures, and maintaining knowledge of sterilization technologies.
Your Key Duties and Responsibilities
* Manage and support environmental processes, product microbiology, and sterilization issues.
* Ensure microbiological evaluation and hygiene monitoring of products and production areas.
* Stay updated on international and regional regulatory standards for sterile and un-sterile medical devices.
* Maintain knowledge of ETO, Irradiation, and Steam sterilization technologies.
* Provide technical direction on environmental and product microbiological controls.
* Develop and implement cost-effective policies and procedures for microbiological controls and sterilization processes.
* Evaluate physical and microbiological parameters of sterilization processes and release sterile products.
Skills & Experience
* Minimum 3 years' experience in the Medical Device Industry.
* Fluent in English, both verbally and in writing.
* Proficiency in MS Office.
* Trained in FDA QSR's, ISO 13485, MDSAP medical device regulations
* Experience as Auditor - preferred
* Experience with sterilization process technology within gas sterilization
* Experience with sterilization process technology within radiation sterilization
Qualifications/Education
* BA degree as Pharmacist, Microbiologist or similar relevant education – university degree
Working Conditions
* Site-based at Deeside Manufacturing site.
Travel Requirements
* The position may involve travel up to 25% of the time. Such travel may involve overnight departures. Position covers Deeside and Rhymney manufacturing sites.