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QA Vigilance Manager

Job Description

We are looking for a Vigilance Manager for our Pathology products, who will provide local and regional support for our vigilance activities with both, internal as well as external stakeholders, such as subsidiaries, distributors, authorities, notified bodies or legal partners of Agilent products. The position is a part of our Global QA/RA organization.

You will be responsible for interacting with various regulatory authorities such as FDA, and supporting various Notified Body related activities as it relates to Vigilance and Post Market Surveillance.

You will lead a great team and have direct responsibility for the preparation, execution and follow up of Recalls/Field Safety Corrective Actions (FSCA), throughout the entire process.

Furthermore, you will work closely with relevant internal partners in RA, R&D, QA, Service/Sales, Production, Marketing, etc. ensuring an effective and efficient execution, in accordance with internal requirements and external regulatory requirements.

One of our missions in Agilent is to help our customers around the world to fight cancer and other life-threatening diseases. We aim at providing the best solutions to ensure accurate and early diagnosis, and to improve treatment and enhance survival rates. This is your chance to contribute!

In this role, you will be responsible for:

  • Lead the Vigilance & Post Market Surveillance team including organizing and facilitating initiation and execution of field actions/recalls, in a timely manner.
  • Involved in Corrective and Preventive Actions (CAPA) activities related to vigilance and complaints.
  • Coordinate with Product/Design responsible SME's in regard to technical product insight and act as a link throughout the vigilance activities.
  • Follow up on Authority requests.
  • Communicate with relevant Pathology/Diagnostic colleagues incl. direct and indirect sales.
  • Provide status reporting to key stakeholders.
  • Ensure efficient and timely customer communication.

  • Additionally, you will team up for:

  • Support QA IT related projects.
  • Process improvements projects.
  • Local activities supporting product investigations and vigilance documentation in accordance with procedures and regulatory requirements.
  • Support post market surveillance.

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