Staff Quality Auditor

November 14

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BD

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

10,000+

Description

• Perform quality audits to support the BD Quality Audit program. • Responsible for carrying out quality audits and ensuring compliance with regulations and corporate standards. • Maintain the audit database and prepare reports for management. • Conduct audits for compliance with medical device standards and corporate policies/procedures. • Interact with individuals at various levels of the organization to perform audits.

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 Certified Quality Engineer Certified Manager of Quality / Organizational Excellence • Knowledge and experience in CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring; Sterilization (EtO, Irradiation) Exemplar Global ISO 13485 Lead Auditor Certification or equivalent (Preferred) • Minimum 8- 10 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. • Minimum of 5+ years’ experience in auditing compliance with domestic and international regulations for medical devices or pharmaceuticals.