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Quality Assurance Associate Post Market Surveillance
4 months ago
**Quality Assurance Associate / Post Market Surveillance**
**Location Worcester**
**Salary - £25000 - 30000 per annum**
**Full time**
Introduction/The Role
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.
**Key requirements**:
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. You will also be able to provide appropriate input during external audits.
**Responsibilities**:
- 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
**Required Job Skills**:
- 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.
**Wright Staff are acting as an employment business in relation to this vacancy.**
**About Wright Staff**:
Supply of driving staff to clients:Wright Staff Recruitment Ltd specialise in the supply of driving staff to clients based in Worcestershire, Gloucestershire and the West Midlands. We pride ourselves on the fantastic service that we provide to both our clients and drivers. We understand all our drivers requirements and make sure we find the work that best suits them, as a result of this we have an excellent record of driver retention and driver satisfaction. All our driver's are PAYE and get holiday pay on a rolling schedule. We are also one of the few agencies that do not charge our clients overtime after 8 hours. Please feel free to call us at any time if you are looking for a new driving position. Permanent Recruitment Solutions:Wright Staff Recruitment Ltd have a number of experienced permanent consultants specialising in a number of different sectors including but not limited to Engineering, Manufacturing, Distribution, Commercial and Sales & Marketing. Our aim is to connect companies with the correct people who will meet the requirements and needs to help develop growth. We offer permanent recruitment solutions for everyone, whether you are an individual job seeker looking or a company looking for permanent placements.Permanent recruitment involves bringing in full time employees that are expected to work and grow with the company. These employees are fully on the payroll of the company and are liable to all the benefits the company is expected to provide by law including tax relief, sick pay, pension entitlements and so on. You will continue to be PAYE (for HMRC purposes).
