Facilities & Office Associate - Trainee
4 weeks ago
My client is a small company in the medical device sector that designs and manufactures several implantable orthopedic devices and their associated surgical instruments. Due to expansion they are looking for a Quality Assurance Associate to join their team in Hallow.
ROLE: To collate clinical data to meet regulatory requirements, and to help develop and maintain the quality system that underpins the business. This person will report to, and provide quality support to the QA/RA Director. The devices my client manufacturs are of high classification, and hence require rigorous post-market surveillance and post-market clinical follow-up studies to be managed under a certified quality management system.
Completion of postmarket surveillance reports including Periodic Safety Update Reports (PSURs) and Summaries of Safety and Clinical Performance (SSCPs)
Management of clinical data collection from a variety of sources including:
Customer complaints
Vigilance databases
Input into vigilance reporting to regulatory authorities
Providing input into customer complaint investigations
Development and implementation of an eQMS
Experience or understanding of the medical or orthopedic industry.
Knowledge of ISO 13485, 21 CFR Part 820, and the Medical Device Regulations is desirable.
Report writing ability
Nest pension
Death in service is 12 months NET
Annual leave is 20 days plus bank holidays plus 1 day per year
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