Johnson & Johnson Karrieren
Sterility Assurance Specialist
Requisition ID: 1805689142W
Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. Our broad array of inspired, innovative and high-quality offerings help advance the health and wellbeing of people around the world.
Sterility Assurance Specialist
- Responsible for the Europe implementation and management of sterility assurance and reprocessing cleaning.
- Ensures compliance to the applicable Medical Device Directive (MDD), ISO 13485, ISO 14971, ISO 9001 and FDA (QSR) regulations as they apply to sterilization and reprocessing cleaning.
Additionally to other applicable Sterilization, Cleaning, and Microbial ISO and EN standards, AAMI standards/reports and other guidance documents as required.
- Provides SA oversight to ensure the adequacy of these activities and documentation in terms of regulatory compliance and technical soundness throughout the European manufacturing system. This should be accomplished by working closely with the Product Development (PD).
Position duties and responsibilities:
- Establish and maintain procedures, tools and methodologies to cover the European sterilization/cleaning program
- Maintain knowledge of ISO, EN & FDA sterilization guidelines
- Conduct technical assessments of contract sterilizers and laboratories
- Train SA personnel to ensure SA program requirements are met
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- Correspond with customers with special requests regarding the Synthes sterilization/cleaning program.
- Provide guidance and training to SA release personnel. Provide input on the resolution of sterility related non-conformances.
- Ensure sterility validations (dose audits, EtO validations…) for all product families are maintained
- Other duties/responsibilities as assigned by manager.
Product Development Responsibilities:
- Work with PD, Synthes USA and vendors to ensure initial product concepts will fit into the Synthes SA system.
- Work with PD to ensure timely and complete sterilization adoptions and validations of all new products.
- Train PD personnel in basic sterilization and in sterilization procedures.
Review all vendor sterility assurance validation protocols and reports to ensure regulatory requirements are met.
- Collaborate with corporate packaging and validation groups to ensure a comprehensive approach to bring new/changed products into production.
- Provide guidance to PD and plant personnel as required ensuring clear, concise and defendable protocols and reports are generated.
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
- Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
- Knowledgeable in applicable Medical Device Directive (MDD), ISO13485, ISO 14971, ISO 9001 and FDA (QSR) regulations.
- Well versed in government regulations and industry guidelines for sterilization (i.e. ISO/EN/AAMI standards) and microbiological control of medical devices.
- This position requires a high level of written and oral communication skills and the ability to interact with managers at all levels as well as personnel at the operating unit level.
- Working knowledge of applicable software, particularly Microsoft Office applications.
- Excellent organizational skills.
- Excellent multi-tasking abilities.
- Vocational qualification plus at least 5 years practical experience and supplementary on-going professional training or Qualification from college or higher education plus 1 years practical experience or University or ETH course with no practical experience
- Englisch fluent
- German advanced
Synthes GmbH (7111)