Quality Internal Auditor
7 hours ago
(7/13/2018 8:46 AM)
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.
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