QMS-Integration & Implementation Lead

at Agilent Technologies, Inc in Wilmington, Delaware, United States

Job Description

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. .

Where will your expertise have most influence? Right here, when you join us in Global Quality Compliance - Systems (GQCS) to become global owner of critical QMS processes (starting with CAPA, NCR, and change control) and drive the global implementation across Agilent. As part of the Agilent-wide OneQMS program you will thrive on the challenge of initiating project and program design and leading the innovation of this high impact and long-ranging strategic initiative.

The global process ownership includes following main responsibilities and objectives:
Assessment of currently existing processes in Agilent, and drive consolidation to a single - OneQMS- process that is used across Agilent.
Definition, documentation and implementation of global QMS processes according to the Agilent -QMS Factory- process
Responsible for process compliance, effectiveness and efficiency of the implementation throughout Agilent (training, consulting, process metrics)
Manage and monitor the process execution across Agilent, identify - prioritize process gaps and challenges
Drive corrective action and continuous improvement of the processes
In addition this person should establish and maintain a network across other global process leads in Agilent.

Technical Qualifications:
Bachelors or Master Degree or University Degree or equivalent.
10- years relevant professional experience.
Profound knowledge of Quality Management System Standards (ISO 9001, ISO 13485, ISO 14971, ISO 17025, ISO 27001, ...)
Profound knowledge of Global Medical Device Regulations (21 CFR part 820, IVDR, NMPA, ...).
Experience with Medical Device Single Audit Program (MDSAP)
Demonstrated experience in the development and improvement of global QMS processes.

Personal Qualifications:
Optimistic, eager, forward-looking and open attitude that supplements our team
Strong teamwork skills and is able to lead, collaborate and work effectively in teams across different businesses, functions and geographies
Self-organized and independent work style with strong customer focus (internal and external customers)
Demonstrated ability to drive alignment across different functions and organizations
Excellent written and verbal communication skills
Willingness to work globally within different time zones

Preferred qualifications
Advanced knowledge and/or certifications of QMS standards (e.g. auditor qualification)
ICH Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients
Understands and effectively interacts with the different levels of an organization

Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases.

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Job Posting: 1076601

Posted On: Nov 21, 2022

Updated On: Dec 02, 2022

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