Agilent Senior RA/QA QMS Auditor
About the Job
Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek ---- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.
The Agilent QMS Auditor is responsible for maintaining the Agilent QMS. 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 assessments for a specific assigned business, region or function following all appropriate internal requirements
- Uses the Audit Schedule to independently plan assigned assessments
- Perform product, process, supplier and other assessments and complete and distribute assessment reports within 30 days
- Verify closure of previous assessment findings
- Summarize internal assessment 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
- 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 effectiveness 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 experts to ensure consistent regulatory interpretations, strategies and programs
Location -- Preferably Santa Clara, CA -- Will consider candidates from Austin, Texas, Wilmington Delaware, Colorado Springs, Colorado, Folsom or La Jolla, California (near a major Agilent facility)