PQV Combination Product Analyst IV

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Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Beerse, Antwerp, Belgium, Ringaskiddy, Cork, Ireland, Schaffhausen, Switzerland

Job Description:

The PQV Combination Product Analyst 4 will be responsible for handling high-volume E2E product quality complaint activities and adverse events, including performing Medical Device Reporting (MDR) assessments.

Additionally, the Analyst IV Combination Products will provide instruction and feedback to the group as needed and ensure completeness and consistency of complaint and MDR documentation.

The position manages and collaborates with business partners and stakeholders (Out Sourced Management Team, Clinical, PV, IT, Local Operating Companies, ESIQ, Call Centers, Brand Protection, External Manufacturing Sites, Internal/External Manufacturing Sites, QA, Business Quality, Medical Safety and R&D) to deliver effective change management, drive process improvements and identify opportunities to improve the accuracy, efficiency and timeliness of the complaint and MDR processes.

This may include risk assessing the impact of proposed changes to the complaint handling/MDR process within and across functional/regional areas and supporting the global change management effectively.

The Analyst IV must have the ability to lead projects and communicate effectively with all levels of management as part of stakeholder engagement and change management roll out.

Position duties & responsibilities:


* Perform high-volume end-to-end complaint handling activities, including, but not limited to: Intake, triage and review of the event reported, determination of MDR reportability, recovery of field samples for evaluation, determination of Priority/Non-Priority, and QP notification to LOC.

Additional activities include due diligence to be performed with the complainant/intake centers/LOC, trend analysis, defect coding, risk criticality assessment, ensuring accurate/holistic investigation, and review and closure.


* Evaluate complaints to determine if the QTL's or ULC's have been exceeded, assess the level of investigation required, and assign to ...