Quality Assurance Officer
1 month ago
Quality Assurance Associate / Post Market Surveillance
Full time
The company is an SME in the medical device sector that designs and manufactures several implantable devices and their associated surgical instruments.
As part of our expansion plans, the company is looking for a PMS/QA Associate to gather and 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, our QA/RA Director.
The devices we manufacture are of high classification, and hence we require rigorous post-market surveillance and post-market clinical follow-up studies to be managed under a certified quality management system.
Ideally, you will have experience or understanding of the medical or orthopedic industry. Knowledge of ISO 13485, 21 CFR Part 820, and the Medical Device Regulations is desirable.
You will be expected to create regulatory documentation to support the companies medical devices and to help maintain the QMS, and by working with others within the business, improve its efficacy. Completion of post-market 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.
* Input into technical file documentation relating to clinical performance and associated risks.
* Assist in the management of the QMS as required by the QA/RA Manager including:
* Providing input into customer complaint investigations
* Development and implementation of an eQMS
Report writing ability.
*
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