Quality Assurance Associate

Hello,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.DUTIES:
* Establishment of postmarket surveillance and post-market clinical follow-up plans
* 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:
* Direct feedback from user surgeons
* Customer complaints
* Patient Reported Outcome Measures (PROMs)
* Product information from joint registries
* Vigilance databases
* Published clinical literature
* Assist in activities of Clinical Research Organisations (CROs) during clinical investigations as required
* Input into Clinical Evaluation Reports (CERs)
* Input into internal product reviews
* Input into vigilance reporting to regulatory authorities
* Providing input into customer complaint investigations
* Providing input into corrective and preventive actions
* Conducting internal audits
* Maintaining SOPs and other QMS documents
* Development and implementation of an eQMSSKILLS:
* Experience or understanding of the medical or orthopedic industry.
* Knowledge of ISO 13485, 21 CFR Part 820, and the Medical Device Regulations is desirable.
* Attention to detail is essential
* Report writing ability
* Strong problemsolving skills
* Ability to work with external partners including orthopaedic surgeons
* Ability to work with staff at differing levels of the organisation
* Competence to assess and upgrade procedures and systems as required
* Strong communication skills
* A team player
* Versatile and a selfstarter able to work without supervision.BENEFITS:Nest pensionDeath in service is 12 months NETAnnual leave is 20 days plus bank holidays plus 1 day per yearLOCATION: HALLOW, WORCESTERSALARY: £25,000 - £30,000 PER ANNUMPLEASE RESPOND TO ME WITH YOUR MOST UP TO DATE CV TO BE CONSIDEREDKind Regards,Maria Roque - Recruitment Consultant
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