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Internal Quality Systems Auditor

Company: Becton Dickinson & Company
Location: South Gate
Posted on: March 17, 2020

Job Description:

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 more areas.

  • 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 best practices.
  • Independently designs quality plans consistent with project objectives.
  • 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 policies.
  • Develops, documents and executes MMS wide Quality Audit Program.
  • 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 management input.
  • 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 SKILLS
    • 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 formal presentations.
    • 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 management techniques.
    • 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 preferred
        • 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, CQM, Etc)
        • 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 LocationsWork Shift

Keywords: Becton Dickinson & Company, South Gate , Internal Quality Systems Auditor, Accounting, Auditing , South Gate, California

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