Internal Quality Systems Auditor
Company: Becton Dickinson & Company
Location: South Gate
Posted on: March 17, 2020
Job Description SummaryThe Internal Quality System Auditor
reports to the WW MMS Quality Systems Sr. Director and is
responsible for the development, improvement and implementation of
the Quality Systems Audit program. They are accountable for
assuring that all Medication Management Solutions (MMS) sites
comply with ISO and FDA (or primary regulations of their respective
countries) through the implementation of effective internal quality
system audit program and ensuing effective corrective actions/
preventive actions.Job DescriptionRESPONSIBILITIESThe Internal
Quality System Auditor is the QMS Subject Matter Expert in one or
- Collects, interprets and analyzes data and presents to others
either orally or in writing. Understands and leverages published
Quality System and regulatory agency requirements and leverages
- Independently designs quality plans consistent with project
- Readily applies Quality System principles to the solution of
complex technical problems.
- Acts independently, consults with supervisor on unusual
situations. May train, develop or assign work to others; provides
technical and or supervisory guidance to others.
- Develops, documents, administers, and maintains Quality Systems
for conformance to regulatory requirements and company
- Develops, documents and executes MMS wide Quality Audit
- Coordinates with other MMS sites to assure that each site has
fully compliant Quality System Audit Program.
- Develops and implements MMS wide audit report Peer Review
program so that audit reporting across the business is uniform,
current and effective.
- Supports MMS wide Quality System Audit Program by providing
independent auditing service when there is a need for support in
any particular site.
- Initiates a MMS wide Audit Data Trending Programs for
- Supports MMS wide continual improvement effort by continually
raising the compliance bar during Quality System Audits.
- Assures appropriate corrective action program is implemented
for nonconformance issued during internal audits.
- Partners with other quality professionals to address recurring
issues identified throughout the organization.
- Provides and analyzes organizational quality audit metrics as
required to generate quality system improvements.KNOWLEDGE AND
- Demonstrated ability to lead, motivate and accomplish results
through experienced direct reports and peers.
- Ability to organize and prioritize assignments providing
direction to assigned functional teams.
- Demonstrates effective written and verbal communication skills
across all levels.
- Ability to speak with clarity and manage conflict resolution in
a variety of settings; one-on-one interactions, group meetings, and
- Ability and skill to effectively manage multiple tasks and lead
execution of change management plans.
- Ability and skill to lead or manage the Quality System function
for complex systems, continuous improvement projects and project
- Ability to act as a liaison across functions and with outside
customer representatives or stakeholders concerning operational or
project schedules/deliverables, audits, etc.
- Thorough knowledge and understanding of the food and Drug
Administration (FDA) 21 CFR 820 and International organization for
Standardization (ISO) and other worldwide regulations.REQUIREMENTS
- At least 7 years experience in Quality Management/Quality
Systems/ Audit Program Management.PREFERRED QUALIFICATIONS
- BS Degree in Life Science, Engineering or equivalent program is
- Certified Lead Auditor 2016 (ISO 13485) is preferred
- RABQSA or equivalent certification is highly preferred. Other
Professional certification is an advantage (i.e, CQA, CQE, SQE,
- FDA and other MD/IVD Regulatory inspection experience is
preferredBecton, 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#LI-OPSPrimary
Work LocationUSA CA - San Diego TC Bldg C&DAdditional
Keywords: Becton Dickinson & Company, South Gate , Internal Quality Systems Auditor, Accounting, Auditing , South Gate, California
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