PQV Combination Product Analyst IV

Johnson Johnson; Beerse; Sur place; EUR 70 000 - 95 000; Plein temps

Résumé du poste

Johnson & Johnson is seeking a PQV Combination Product Analyst 4 in Beerse to manage high-volume E2E quality complaint activities and MDR assessments. You will work with internal teams and external sites to ensure accurate investigations and timely regulatory reporting.

The role requires strong leadership across QA and regulatory functions, with risk-based decision making and effective communication with management levels.

Responsabilités

• Perform high-volume end-to-end complaint handling activities including intake, triage, event review, MDR reportability, field sample recovery, priority assignment, and regulatory notification.
• Evaluate complaints to determine investigation scope and assign to appropriate sites.
• Govern daily throughput of complaints and MDR decisions to meet KPI targets.
• Conduct MDR evaluations with writtenJustification to support reportable and non-reportable regulatory decisions.
• Monitor complaints for new malfunction events for potential inclusion in MDL.
• Act as PQV point person for post-market/complaint regulatory questions and provide guidance to junior staff.
• Assess information technically to ensure accurate risk prioritization and investigations per procedures.
• Back-up PQVIS personnel to support volume fluctuations.
• Collaborate with Global Medical Safety, manufacturing sites, LOC/BQ for effective complaint handling/MDR assessments.
• Provide feedback for escalation and future product development based on product knowledge.
• Ensure timely management of complaint records and regulatory reporting per standards.
• Compile/analyze data, metrics, and trends related to complaint handling.
• Support audits/inspections and serve as SME during regulatory reviews.
• Engage with regulatory authorities and J&J councils to discuss evolving quality system trends.
• Provide workflow leadership to PQV peers for end-to-end complaint management.

Description du poste

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Beerse, Antwerp, Belgium, Ringaskiddy, Cork, Ireland, Schaffhausen, Switzerland

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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 the applicable site for investigation.
• Governance and oversight for daily thru put of complaints and MDR decisions to ensure prioritization and KPI are met.
• Perform MDR evaluations and document written justification to support reportable and non-reportable regulatory decisions.
• Monitor complaints for new malfunction events that may require inclusion in the malfunction description list (MDL).
• Serve as a PQV point person for post market and complaint handling regulatory/MDR questions and inquiries; provides guidance and direction to subordinate Analyst roles and other PQV functions.
• Evaluate information from a technical perspective to ensure appropriate analysis and investigations/ MDR's are accurately assessed for risk prioritization and performed per procedures, standards, and regulations.
• Back-up Product Quality Vigilance Investigation Support (PQVIS) personnel to support increased volume of complaints.
• Strong collaboration with Global Medical Safety, manufacturing sites, and LOC/BQ for effective complaint handling/MDR assessments and adverse events with potential product quality issues.
• Use technical and product knowledge to provide accurate feedback for escalation/awareness of issues and for current product enhancements/future product development, if applicable.
• Ensure that uniform and timely management of complaint records and regulatory reporting occurs per procedures, standards, and regulations.
• Compile and analyze data, metrics, and trends associated with the complaint handling processes.
• Support internal and external audits and inspections; ability to communicate regulatory and process positions as an SME during regulatory inspections and provide follow-up support as required.
• May interact with regulatory authorities, other J&J operating companies, and J&J global councils to interpret and influence emerging quality systems regulatory trends.
• Provide product workflow leadership to PQV peers to ensure consistent and fully understood End-to-End complaint management process