Product Quality Vigilance
6 days ago
Essential Duties and Responsibilities:
The PQV Analyst will be responsible for handling E2E product quality complaint activities and adverse events, including performing Medical Device Report (MDR) assessments. Additionally, the role will manage the team's processes to ensure completeness, consistency, and accuracy. The position identifies opportunities and recommends solutions to improve the accuracy, efficiency, and timeliness of the complaint and MDR 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.
The PQV Analyst must have the ability to assist with various projects within the department and communicate effectively with all levels of management.
Qualifications:
- 1-5 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.
- Knowledge of medical safety environment and regulation.
- Global mindset and demonstrated ability for change initiatives, project management, and developing strong relationships.
- Working knowledge of and 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.
- Bachelor's degree or Master's degree (preferred) in technical, scientific, or engineering disciplines required. Biomedical Engineer, Registered Pharmacist, Registered Nurse, Physician Assistant, or similar healthcare provider/science license/certification/degree preferred.
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