Internal Quality Auditor EMEA based FRANCE
BD
Le Pont-de-Claix, Auvergne-Rhône-Alpes
il y a 6j

Job Description Summary

The Staff Quality Auditor I 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 Director, Corporate Quality 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.

Quality Auditor

A superb, wide-ranging Staff Quality Auditor career development role with BD, a global leader in Medical Technology. We are hiring 3 positions in total in various European location to cover EMEA scope.

The suitable candidate for this role will be based in France.

BD is a global medical technology company focused on improving drug therapies, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines.

BD provides an environment which enables our highly talented workforce to be the best at their professions. We are always seeking people who have a passion and commitment to join our Company on its journey to helping all people live healthy lives’.

The Staff 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.

Primary Responsibilities and Duties

  • 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.
  • May perform other duties as required
  • Education & Experience Requirements

  • Extensive knowledge and ability to apply international regulations and standards of FDA QSR, ISO 13485, EU MDR / IVDR, and ISO 14971 standards.
  • Knowledge and experience in CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring;
  • MDSAP; Sterilization (EtO, Irradiation)

  • Excellent verbal and written communication skills required
  • 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
  • Bachelor’s degree in Engineering, Chemistry, Biology, or other related discipline
  • Must have one of the following certifications or equivalent from an accredited organization : Certified Quality Auditor / ISO Lead Auditor Certified, Certified Quality Engineer, or Certified Quality Manager
  • A minimum of 5 years work experience in the Quality organization of a Medical Device and / or Pharmaceutical company
  • A minimum of 3 years’ experience in auditing compliance with domestic and international regulations for medical devices or pharmaceuticals.
  • Experience using electronic QMS (e.g. Trackwise) preferred
  • Fluent level of English (any other European language is a plus)
  • Additional Requirements

  • Requires 30-50% domestic and international travel
  • Must be able to enter Laboratory and Manufacturing environments that may have specific PPE and health requirements.
  • It’s a superb, all-round Staff Quality Auditor I career development role with a world leader in medical devices. So if this describes you and your aspirations, then please click on the APPLY button.

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