at Agilent Technologies, Inc in DoverDover, Delaware, United States
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 .
We are looking for a new Vigilance Specialist to help improve the product quality of our Pathology products. As Vigilance specialist you will provide local and regional support for activities that require Agilent technologies to reach out to internal stakeholders, subsidiaries, distributors, authorities, notified body or legal partners of Agilent products.
In this position you will be responsible for:
Supporting local and regional vigilance activities as requested and determined by the Vigilance team manager
Supporting daily operation in terms of vigilance evaluations, escalations of NCRs and product investigation raised locally
Organizing local meetings to facilitate execution of field actions/recalls
Ad hoc participation in CAPA activities related to vigilance and complaints.
Your primary tasks -Issue evaluation
Provide daily support of potential cases that need to be evaluated and escalated for Vigilance reporting.
Support enterprise vigilance team with local coordination in connection with initiation of field actions/recalls
Provide feedback regarding necessary updates to risk assessment documentation and support as required
Prepare data and research for input into metrics, trending, risk assessments, health hazard assessments
Follow up to ensure field actions/recalls can be executed in a timely manner
Ensure involvement of Medical Director and other internal stakeholders as required.
Additional tasks in Vigilance Team
Process improvements projects
Prepare local activities supporting product investigations and vigilance documentation in accordance with procedures and regulatory requirements
Support post market surveillance
You will be communicating both internally and externally:
Communicate with the broader Agilent organization as appropriate in relation to activities related to the job function.
Close communication with vigilance and complaint team member - to align cases.
Communication with subject matter experts (SME's) in other organizations
Communication with FDA and other regulatory authorities as needed
Preferably M.Sc. or B.Sc. degree in a scientific or technical discipline or other relevant technical education.
4+ years of experience
Experience with vigilance documentation/activities and Corrective and Preventive Actions, from both a Quality Assurance and Regulatory perspective.
Strong written and oral communication skills (in English) to a global organization including contact to distributors.
Thoroughly versed in Quality System Standards e.g. ISO 13485, FDA CFR 21 Part 803, 806 and 820 and similar global regulations, including preferably IVD/Medical Device legislation in the USA (MDR) and EU (MEDDEV).
Track record of applying good judgement in determining if reported issues and complaints are reportable based on IVD/Medical Devices or similar legislation.
Skilled in effectively and efficiently documenting events and findings.
Experience with data analysis, troubleshooting, problem solving in compliance with the regulation and presentation of results.
Demonstrate ability to collaborate across different functions.
Experience in stakeholder management. Understands the importance of knowledge-sharing and relationship maintenance to emphasize the field action activities of Quality Assurance and Regulatory Affairs.
Preferably antibody, probe production and QC knowledge (IHC, ISH), knowledge of instrumentation used for IHC and ISH tests.
Result oriented, proactive, ambitious, flexible and creative
Capable of working independently, however at the same time active in teamwork
Training and development opportunities
A commitment to work/life balance
A... For full info follow application link.
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.