Job Description Summary

This position is responsible for the performance of audits in support of the BD Quality Audit program.
In this role, he/she is responsible for carrying out quality audits to support the various audit programs impacting BD sites.
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.

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

• Conducts Quality Audits to ensure compliance with domestic and international medical device standards and regulations, local procedures, and corporate policies/procedures.
• 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.
• This individual's primary responsibility will be to perform quality internal audits of the various locations' Quality management systems, which may result in the identification of compliance risks that need to be addressed by the business to improve its compliance position and influence the quality strategy by the management team.
• This individual will also be responsible for executing the department's projects and strategic initiatives.
• This individual will interact with individuals at various levels of the organization across multiple sites when performing audits at these assigned locations, including top management.

• 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
• 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)