Post Market Quality Manager (IVD)

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. Information about Agilent is available at 

Position Overview

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 this role, you are making a difference in someone’s life.

This role will provide leadership to a team of Quality professionals supporting global post market quality activities for the DGG division. The successful candidate will take responsibility for the existing processes, implement new requirements ( IVDR), and align to enterprise level QMS requirements. They will work with cross-functional teams to execute, improve, maintain and monitor these processes and will present these in any internal audits or external inspections. A good working knowledge of, and experience with, both ISO 14971 and the In-Vitro Diagnostic Regulations (IVDR) is required.

Responsibilities:

Oversee and improve post market quality processes in compliance with ISO 14971, IVDR, and other applicable global regulations

Deployment of procedures, systems, tools, and training to cross-functional teams to ensure creation and maintenance of:Post Market Surveillance Plans and ReportsProduct Safety Update ReportsPost Market Performance Follow-Up Plans and Reports

Manages team of employees responsible for the post-market quality of DGG products / product families, including:Collection of post market data from functions across the organizationStatistical analysis and visualization of post market dataLead cross-functions meetings for review of post market dataEnsure update of documentation (risk management file, design history file, technical documentation) and completion of corrective actions based on the outcomes of the reviews.

Partner with commercial organization to ensure an effective process to collect non-complaint customer feedback

Partner with medical / clinical organization to coordinate PMS reviews with Post Market Performance Follow-Up (PMPF) and Periodic Safety Update Reports (PSURs)

Act as subject matter expert during internal audits and external inspections.

Qualifications

Bachelor or Master’s degree in Engineering or Scientific/Technical discipline

Several years’ relevant professional experience.

Strong expertise in risk management per ISO 14971

Demonstrated experience in a leadership role with influence.

Thorough understanding of 21CFR820, 822, ISO 13485, EU IVDR, & MDSAP

Experience in Project Management and Change Management.

Ability to operate effectively in a team environment and independently with little direction.

Ability to lead by example, hold yourself and others accountable and coach others

Strong verbal and written communication skills

Results oriented and willing to take accountability.

Positive ‘can do’ attitude.

Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.

Option to Work Remote

Yes

Travel Required

Occasional

Schedule

Schedule:Full time

Shift

Day

Duration

No End Date

Job Function

Quality/Regulatory