C. R. Bard, Inc.

  • Quality Internal Auditor

    Posted Date 1 week ago(7/13/2018 8:46 AM)
    Job ID
    2018-11799
    Career Level
    experienced
    Division
    BDI Corporate
    Relocation
    No
    Location
    US-NJ-Murray Hill
  • Summary of Position with General Responsibilities

    The Quality Auditor is responsible for performance of audits in support of the BD Corporate Quality Internal Audit program.   In this role, he/she is responsible for carrying out audits under the direction of the Senior Manager and/or Director Corporate Internal Audit. In addition, he/she will work with the sites to ensure submitted objective evidence is compliant with domestic and international regulations, corporate standards, and local procedures. He/she will maintain the audit database to monitor audit program metrics and prepare reports for management.

    Essential Job Functions

    • Conduct Corporate Quality Internal Audits to assure compliance with domestic and international medical device standards and regulations, local procedures, and corporate policies/procedures.
    • Follow up with the auditee as required to compile information relating to the audits.
    • Evaluate the adequacy of the provided evidence against the approved Audit Action Plan (AAP). In conjunction with management, develop plans to address inadequate AAP documentation when required
    • Maintain the audit system software database to record the status of all audits and associated actions. 
    • Provide periodic reports to management based on the audit statuses and defined metrics.
    • Maintains a high degree of personal professional development through a combination internal and external training and participation in professional associations as appropriate.

    Basic Qualifications

    • Bachelor’s degree in Engineering, Chemistry, Biology, or other related discipline
    • A minimum of 3+ years work experience in the Quality organization of a Medical Device and/or Pharmaceutical company
    • A minimum of 2+ years experience in with auditing compliance with domestic and international regulations for medical devices or pharmaceuticals.
    • Knowledge and experience in CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring; Sterilization (EtO, Irradiation)
    • Knowledge and ability to apply international regulations and standards of FDA QSR, ISO 13485, EU MDR, and ISO 14971 standards
    • Excellent verbal and written communication skills
    • Demonstrated ability to effectively collaborate and partner with all levels of management while maintaining an appropriate assertive style is critical.
    • Strong analytical skills
    • Effective project management and organizational skills are essential.
    • One of the below certifications or equivalent:

      • Certified Quality Auditor/ISO Lead Auditor Certified
      • Certified Quality Engineer
      • Certified Quality Manager

     

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