- 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.
- 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.
- Ensure uniform and timely management of complaint and MDR records from receipt to closure.
- Ensure investigations are accurately assessed for risk prioritization and performed per procedures, standards, and regulations.
- Evaluate complaints to determine if the QTLs or ULCs have been exceeded, assess the level of investigation required, and assign to the applicable site for investigation.
- Back-up Product Quality Vigilance Investigation Support (PQVIS) personnel to support increased volume of complaints.
- Support internal and external audits and inspections; ability to communicate regulatory and process positions as an SME during regulatory inspections.
- Provide product workflow leadership to PQV peers to ensure consistent and fully understood End-to-End complaint management process.
- Ability to allocate and balance competing priorities in driving business results.
- Works independently, challenges the status quo, identifies gaps and drives process improvements using Process Excellence tools. Participates and/or leads special projects.
- Develop and deliver training for colleagues and stakeholders on the complaint handling process, product specific training, and complaint handling system updates/changes.
- Exhibit strong ability to collaborate and influence Business Partners to ensure appropriate complaint handling and improved complaint management processes.
- Evaluate and review complaint data trends, KPI trends, and product report trends.
- Support the development, revision, and / or maintenance of applicable documents (WI/Job Aids/SOPs).
- Bachelors degree in technical, scientific, or engineering required. Masters Degree is preferred. Biomedical Engineer, Registered Nurse, Physician Assistant or similar healthcare provider/science license/certification/degree preferred.
- 1-3 years of related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceutical and/or Medical Device or other related highly regulated industry is required.
- Knowledge of medical safety environment and regulation.
- Global mindset and demonstrated ability for change initiatives, project management and develop positive relationships.
- Experience with the following regulatory requirements: 21 CFR parts 4, 820, 803, 806, 210, 211, 314, ISO 13485:2003, ISO 14971:2007/2012, ICH Q10, GDP, GMP, GVP, MEDEV 2.12, CMDR and the Medical Device Directive 93/42/EEC.
- Experience working with Pharma or Medical Device regulation is required.
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Quality Complaints Coordinator - Horsham, United States - Medasource
Description
Quality Complaints Coordinator
Horsham, PA
1 year contract
The Quality Complaints Coordinator will be responsible for handling E2E product quality complaint activities and adverse events, including performing Medical Device Report assessments. Additionally, the role will need to manage the teams processes to ensure completeness, consistency, and accuracy. The position finds opportunities and recommends solutions to improve the efficiency, and timeliness of the complaint and Medical Device Report processes. The position collaborates with business partners and stakeholders (Out Sourced Management Team, Internal/External Manufacturing Sites, Clinical, PV, IT, Local Operating Companies, ESIQ, Call Centers, Brand Protection, QA, Business Quality, Global Medical Safety and R&D) to drive process improvements and deliver effective change management.
Key Responsibilites:
Qualifications:
Education:
Experience and Skills:
