Job Summary
As a healthcare company committed to protecting the health and safety for our employees, contractors, customers and communities, employees in this role are required to be fully vaccinated against COVID-19, unless an accommodation has been granted for a medical reason or sincerely held religious belief.
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.
We are looking for a Lead Auditor! The Global Regulatory Compliance Lead Auditor is responsible for leading a group of global auditors responsible for maintaining the Agilent QMS. The Agilent QMS includes products and processes associated with ISO 9001, ISO 13485 and various Medical Device country regulations, including the Quality System Regulation (QSR) of the USFDA.
The 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 audits
Develop assessment strategy, scope, and plan and present to the Global Regulatory Compliance Program Manager
Perform product, process, supplier, and other assessments and complete and distribute assessment reports within 30 days
Verify closure of previous assessment findings and perform gap analyses for Business partners
Summarize internal assessment findings for management review
Educate others in quality and regulatory standards and consult in the development of processes and procedures consistent with those standards
Consult regularly with the Global Regulatory Compliance Program Manager and Agilent Global Quality and Regulatory Affairs Management Leadership Team
Share best practices within the Business Groups throughout the Agilent community
Keep skills current. Keep abreast of changing standards and regulations and share information as appropriate
Participate in improvement efforts of the internal audit process
Assist Business QMS Leads with QMS activities and partner for 3rd party audits when required
Generate and distribute metrics illustrating the efficiency of the Internal Audit Program
Provide guidance to internal customers on how to best to maintain Certifications in the midst of changes in external regulations, internal changes in product development strategies and providing expertise in translating regulatory/ISO standard requirements into practical, workable plans
Develop and manage travel schedules to ensure timely and effective audits for internal customers
Helping sites/businesses formulate strategies for new product introduction and/or development
