Contamination Control Specialist
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Flex is a leading sketch-to-scale solutions company that designs and builds intelligent products for a connected world. With more than 200,000 professionals across 30 countries and a promise to help make the world Live smarter™, the company provides innovative design, engineering, manufacturing, real-time supply chain insight and logistics services to companies of all sizes in various industries and end-markets.
Flex operation in Timisoara serves customers in the automotive, medical, industrial and networking market sectors, having more than 4000 employees. Our manufacturing capabilities include printed circuit board assembly, new product introduction, box-build and high level system assembly. We also provide a full range of clean room product assembly for medical disposable devices.
Monitors Clean Room environmental conditions (temperature, humidity, pressure differential, contamination with microorganism);
Serve as the Subject Mater Expert for sterilization/microbiological activities to ensure compliance to FDA and international regulatory laws/standards;
Perform studies to:◦support parametric release;
◦support equivalency of sterilizer systems;
◦support standards compliance;
◦support sterilization validation of new products/new product development;
◦support microbiology testing;
◦support regulatory submission;
◦support research of new sterilization/ clean room technologies;
◦support biocompatibility qualification on new products;
◦support ongoing manufacturing and product changes related to biocompatibility testing, sterilization validation, and sterilization re-validation.
Influence the global team to develop and implement strategies across multiple sites;
Develop and maintain strategic relationships with suppliers, business partners and takeholders;
Defines direction and leads the development and implementation of new processes, standards or operational plans based on global business strategy;
Makes recommendations to Flex Medical leadership.
Microbiology degree or other related biological degree with related experience;
3 years’ experience in microbiology/sterilization function in the medical device or related industry;
Detailed knowledge and experience with ISO 10993, ISO 11135, ISO 11137, ISO 11607 and ISO 11737 standards for biocompatibility and sterilization;
Detailed knowledge and experience with ISO 14644, ISO 14698, EU GMP, FDA requirements for Clean Rooms;
Knowledge of relevant aspects of ISO 13485 and FDA Part 820 Quality System Regulation;
Advanced English - technical writing and oral communication skills;
Computer literate, having experience with MS word, Access and Excel;
Travel percentage 10%.