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Regulatory Compliance Internal Auditor

Organization
Agilent
Job Location
5301 Stevens Creek Blvd
Santa Clara, CA 95051
United States
Job Description

The Agilent Enterprise Regulatory Compliance Internal Auditor is responsible for ensuring compliance with the Agilent QMS and applicable global regulatory regulations. The Agilent QMS includes products and processes associated with ISO 9001, ISO 13485 and various Medical Device regulations, including the Quality System Regulation (QSR) of the USFDA. Auditor responsibilities include:

  • Act as a focal point for internal audits for assigned business, regions or functions following all appropriate internal requirements
  • Uses the Audit Schedule to independently plan assigned internal audits
  • Perform product, process, and other audits (e.g., supplier) and complete and distribute audit reports within 30 days
  • Verify closure of previous audit findings
  • Summarize internal audit findings
  • Educate others in quality and regulatory standards and consult in the development of processes and procedures consistent with those standards
  • Perform gap analyses for Business partners as needed
  • Keep skills current. Stay abreast of changing standards and regulations and share information as appropriate
  • Maintain external certification as a quality auditor from a recognized authority, e.g. ASQ/RAB. Certification is not required but if available must be maintained.
  • Participate in improvement efforts of the internal audit process
  • Assist Business Group QMS Manager with QMS activities and other tasks as requested
  • Attend required meetings, e.g. audit team, department meetings, etc.
  • Generate and distribute metrics illustrating the efficiency of the Internal Audit Program
  • Develop and manage travel schedules to ensure timely and effective audits for internal customers.
  • Facilitate conversations with Business RA and QA as needed
  • Collaborate with Agilent's medical device regulatory specialists to ensure consistent regulatory interpretations, strategies, and programs

Location -- Preferably near an Agilent facility in the USA (e.g., Santa Clara, CA; Austin, Texas, Wilmington Delaware; Folsom, CA; La Jolla, CA or Boulder, CO.) or located near a major airport or airline hub.

Requirements

Education:
* Bachelor's Degree in science or related field is required

  • Prior experience auditing Medical Device products (e.g. FDA 21CFR-820, 801/809, 803/806) from a complete product lifecycle perspective, a must.
  • Prior experience with ISO 9001, ISO 13485; ISO 14971 a must.
  • Understanding of 21CFR 210 and 211 (FDA Pharmaceutical regulation) would be beneficial.
  • Proficient written and verbal professional social skills.
  • Ability to travel globally 40-70% of the time (50% typical)
  • Willingness to work staggered hours to ensure coverage for internal customers across the globe
  • Experience with EU IVDR and Canadian Medical Device Requirements a plus (but not required)
  • Experience with Clinical Trials/Clinical Affairs a plus (but not required)

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