Staff Quality Auditor I
December 14
Description
• This position is responsible for performance of audits in support of the BD Quality Audit program. • Responsible for carrying out quality audits to support various audit programs. • Work with sites to ensure submitted objective evidence is compliant. • Maintain the audit database to monitor audit program metrics and prepare reports.
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.
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November 14
Perform audits for medical technology company BD's quality systems.