BD (Becton, Dickinson and Company) Quality Specialist 3, Internal Audit in San Diego, California

Job Description Summary

Job Description

Summary

Responsible for the performance of internal audits of the quality management system related to FDA, MDSAP and ISO compliance. Supports the business in the identification and resolution of quality assurance and regulatory issues related to audit findings to assure compliance with FDA regulations, ISO standards, corporate directives and company strategies.

Duties & Responsibilities

  • Creates and maintains an internal audit plan based on defined inputs.

  • Conducts internal audits as detailed by the plan.

  • Creates audit reports and conducts closing meetings.

  • Assists audit finding owners with the root cause investigation and development of effective corrective actions as required.

  • Works with audit finding owners to evaluate risk of nonconformance.

  • Follows up on the implementation and effectiveness of the corrective actions completed in response to internal audit findings.

  • Creates, maintains and reports relevant internal audit metrics.

  • Participates in the maintenance and improvement of the internal auditing procedures, processes, and documentation.

Qualifications

  • B.S. or B.A. Degree required.Degree in a science or engineering field preferred.

  • Minimum of 5 years’ experience performing audits required.

  • Working knowledge ofQSR, ISO 9001:2015 and 13485:2016 regulatory standards required.

  • Previous experience with medical devices in a regulated environment (i.e. QSR, GMPs, ISO 13485, EN46001, etc.) is strongly preferred.

  • Excellent verbal and written communication skills.

  • Ability to work independently with minimal guidance.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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

Primary Work LocationUSA CA - San Diego TC Bldg C&D

Additional Locations

Work Shift

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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