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Coord 3, Quality Auditing / Systems

Description:

  • 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.
  • 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.

Must haves:

  • Auditor Certification or Equivalent
  • Experience Performing Audits is 2+ years (Resume must indicate that individual has been in the role of an auditor and not just supporting audits)
  • 3+ years in the Medical Device or Pharma Industry
  • Knowledge and ability to apply ISO 13485, 21CFR820, etc.
  • Written Communication Skills


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