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.

Job 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.

Please apply with your CV in the first instance.

Wright Staff are acting as an employment business in relation to this vacancy.