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.

Agilent is currently seeking an experienced Quality Leader to join the team in Diagnostics and Genomics Group (DGG). Within DGG, we serve our customers who are deeply involved in improving human health. Whether it is to fight cancer or to improve the quality of life for those with a genetic disorder, patients are benefiting from the trusted answers our products deliver. Every day in this role, you are making a difference in someone's life.

Position Overview

This management role will provide leadership to the DGG organization in the creation, implementation, maintenance and continuous improvement of Quality Management System (QMS) processes and systems in compliance with global in-vitro diagnostic (IVD) medical device regulations.

Principle Duties / Responsibilities

• Provide leadership to QMS process owners and develop and implement improvement programs at the site, division, and DGG level.
• Represent DGG in global QMS harmonization and IT system projects and coordinate implementation activities across DGG.
• Act as the Training process owner and support implementation of a global Learning Management System (LMS).
• Oversee establishment and analysis of quality metrics (KPIs) to assess the effectiveness of the QMS and drive improvements.
• Oversee preparation and provide direction on the content of Quality Management Review (QMR) in alignment with global standards and initiatives.
• Ensure implementation of current applicable regulatory requirements (In Vitro Diagnostic medical devices Regulation (IVDR) (EU) 2017/746, ISO13485, FDA CFR 21 Part 820) as well as evaluation of new/changed requirements.
• Support audit preparedness to comply with authority, notify bodies, customer, and internal audits.
• Develop team capabilities and create standard work with the goal of establishing a center of excellence for QMS process management within DGG.

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Qualifications

• Bachelor or Master's degree in Engineering or Scientific/Technical discipline
• Minimum of 7 years professional experience in Quality in the medical device industry
• Minimum of 7 years supervisory experience (managing direct reports), including hiring, training, coaching and performance management activities
• Strong knowledge and understanding of standards and regulations: ISO 14971:2019, Regulation (EU) 2017/746, FDA CFR 21 Part 820, ISO 13485
• Direct experience in managing QMS processes under above regulations
• Strong analytical skills with focus on finding the right solutions in compliance with the regulations.

Salary

The US pay range for this full-time position is $115,680.00 - $213,285.00/yr, plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum new hire pay for the position across the relevant US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Additional details are available at: