BD is looking for a Staff Quality Auditor to be responsible for the implementation and oversight of the BD Quality Audit program. You will conduct quality and regulatory audits, provide training and guidance for auditors, and monitor corrective actions.

What You'll Do

Coordinate and conduct routine and focused quality system audits to assess compliance with regulations, standards, and procedures.
Establish audit teams using qualified BD quality auditors and contracted auditors.
Conduct Quality Audits to assure compliance with domestic and international medical device standards and regulations.
Follow up with the auditee to compile information relating to audits.
Evaluate the adequacy of provided evidence against the approved Audit Action Plan (AAP).
Maintain the audit system software database to record the status of all audits and associated actions.
Provide periodic reports to management based on audit statuses and defined metrics.
Maintain a high degree of personal professional development through internal and external training.
Work in an office setting and travel 25 - 50% domestically and internationally.
Enter Laboratory and Manufacturing environments that may have specific PPE and health requirements as part of audits.

What We're Looking For

B.S. Engineering, Chemistry, Biology or equivalent field.
One of the below certifications or equivalent: Certified Quality Auditor/ISO Lead Auditor Certified, Certified Quality Engineer, Certified Manager of Quality / Organizational Excellence.
Minimum 10 years of experience in the Quality organization of a Medical Device and/or pharmaceutical company.
Minimum of 5+ years experience auditing compliance with domestic and international regulations for medical devices or pharmaceuticals.
Demonstrated knowledge and experience in CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring; Sterilization (EtO, Irradiation).
Extensive knowledge of medical device regulations and standards (FDA QSR, ISO 13485, MDSAP, EU MDR/IVDR).
Comprehensive understanding of auditing principles and ability to perform as a lead auditor.
Demonstrated ability to effectively collaborate and partner with all levels of management.
Excellent communication skills (verbal, written, and presentation).
Strong analytical skills.
Effective project management and organizational skills.
Ability to effectively handle time and resources.

Nice to Have

Advanced degree.
Exemplar Global ISO 13485 Lead Auditor Certification or equivalent.
Experience with warning letters and other regulatory actions.
Advanced knowledge of other international medical device regulations (e.g., China, Saudi, Korea, etc.).

Benefits & Compensation

Salary: $130,400.00 - $215,200.00 USD Annual

Work Mode

This is a hybrid position based in USA NJ - Franklin Lakes.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.