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Johnson & Johnson Karrieren

Sterility Assurance Specialist

Zuchwil, Schweiz
Quality (Eng)


Arbeitsplatzbeschreibung

Requisition ID: 1805689142W

 
DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the are of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial,power tools and biomaterials.
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.
 
 
The groupe is supporting the product development in the sterility assurance in compliance with the country regulations and general sterilization standards. Additional evaluation of reprocessing of medical devices is part of the teams investigation. The passion to protect and the power to prevent.
 
 

                                   Sterility Assurance Specialist

 
 
Overall responsibilities:
  • 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
    LSYN_010253 V1.3 07/16/2015 
  • 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.

Compliance Responsibilities:
  • 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.
 
Extended duties:
  • 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.

Qualifikationen
 
  • 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



Primärer Standort
Schweiz-Solothurn-Zuchwil-
Organisation
Synthes GmbH (7111)
Funktion
Quality (Eng)
Requisition ID
1805689142W