Quality Audit and Compliance Specialist

November 14

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BD

Medical Devices • Biosciences • Medical Supplies • Laboratory Instruments • Reagents

10,000+

Description

• This position is responsible for the performance of audits in support of the BD Quality Audit program. • Conducts Quality Audits to ensure compliance with domestic and international medical device standards and regulations. • Follows 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. • Maintains the audit system software database to record the status of all audits and associated actions. • Provides periodic reports to management based on the audit statuses and defined metrics. • Maintains a high degree of personal professional development through a combination of internal and external training and participation in professional associations as appropriate.

Requirements

• B.S. Engineering, Chemistry, Biology or equivalent discipline, advanced degree is preferred. • One of the below certifications or equivalent: (Required) • Certified Quality Auditor/ISO Lead Auditor • Certified Quality Engineer • Certified Manager of Quality / Organizational Excellence • Exemplar Global ISO 13485 Lead Auditor Certification or equivalent (Preferred) • Minimum 3 years of work experience in the quality organization of a medical device and/or pharmaceutical company. • Experience with warning letters and other regulatory actions is preferred. • Experience in auditing compliance with domestic and international medical device or pharmaceutical regulations. • Knowledge and experience in CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring; Sterilization (EtO, Irradiation).

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