Contamination Control Specialist

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Employer: Flex Romania
Domain:
  • Quality Control
  • Engineering
  • Production
  • Job type: full-time
    Job level: 1 - 5 years of experience
    Location:
  • Timisoara
  • Updated at: 11.06.2019
    Remote work: On-site
    Short company description

    Flex creează produse extraordinare pentru clienţi, care aduc valoare şi îmbunătăţesc vieţile oamenilor. Cu o istorie de manufacturiere şi realizare de produse de peste 50 de ani, în centrul activităţilor şi operaţiunilor noastre se află comunitatea Flex de ~170.000 de membri în 30 de ţări.

    Requirements

    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:â—¦support parametric release;
    â—¦support equivalency of sterilizer systems;
    â—¦support standards compliance;
    â—¦support sterilization validation of new products/new product development;
    â—¦support microbiology testing;
    â—¦support regulatory submission;
    â—¦support research of new sterilization/ clean room technologies;
    â—¦support biocompatibility qualification on new products;
    â—¦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.

    Responsibilities

    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%.

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