BD (Becton, Dickinson and Company) Staff Quality Auditor I (BD's Quality Systems Internal Auditor) in Covington, Georgia
Job Description SummaryThe Staff Quality Auditor I is responsible for the performance of audits in support of the BD Quality Internal Audit program.In this role he / she is responsible for carrying out audits under the Direction of the Associate Director Corporate Quality Audit. In addition she / he will work with the audited sites to ensure submitted evidence is compliant with domestic and international regulations, corporate policies and procedures, and local procedures. She / he 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 standards and regulations, corporate policies and procedures and local procedures.
Follow up with the audited site as required to compile information related 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 status and metrics.
Maintain a high degree of personal professional development through a combination of internal and external training and participation in professional associations as appropriate.
May perform other duties as required
Requires 30-50% domestic and international travel
Must be able to enter laboratory and manufacturing environments
Bachelor’s degree in Engineering, Chemistry, Biology, or other related discipline
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 with auditing compliance with domestic and international regulations for medical devices or pharmaceuticals.
One of the below certifications or equivalent:
Certified Quality Auditor/ISO Lead Auditor Certified
Certified Quality Engineer
Certified Quality Manager
Exemplar Global ISO 13485 Lead Auditor Certification or equivalent (Preferred)
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.
***This position can be located out of any BD site in the United States.
Becton, Dickinson and Company is an EqualOpportunity/AffirmativeAction Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.
Primary Work LocationUSA NJ - Franklin Lakes
Additional LocationsUSA CA - San Diego TC Bldg C&D, USA CA - San Jose, USA GA - Covington BMD, USA IL - Vernon Hills, USA MD - Sparks - 7 Loveton Circle, USA NC - Research Triangle Park, USA TX - El Paso - Northwestern Dr., USA UT - Sandy
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.