Quality Assurance Associate Post Market Surveillance
Wright Staff
- Worcester
- £25,000-30,000 per year
- Permanent
- Full-time
- Establishment of post-market surveillance and post-market clinical follow-up plans
- 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:
- 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.
- 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
- Providing input into corrective and preventive actions
- Conducting internal audits
- Maintaining SOPs and other QMS documents
- Development and implementation of an eQMS
- Attention to detail is essential.
- Report writing ability.
- Strong problem-solving 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 self-starter able to work without supervision.
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