Kingston Upon Hull, East Riding of Yorkshire
£30 - £36 per hour
about 1 month ago
One of the world's largest and most innovative sustainable medical technology organisations has an urgent requirement for an interim Quality Assurance Specialist.
This Is an interim contract offering up to £36 p/h inside IR 35 for a candidate to be based in Hull.
Responsible for reviewing Post market surveillance (PMS) data, ensuring that the safety, performance, and quality of existing products conform to established standards and are in compliance with all applicable global Quality System Regulations.
- Review PMS reports and ensure timely update to risk management files where new/increased risks are identified through PMS activities.
- Support the timely review of risk management files in line with the complaints management process.
- Support the timely review of PMS data as part of monthly PMS trending.
- Ensure compliance to cGMP, cGDP, ISO 13485, US FDA 21 CFR Part 820 and any other applicable quality standards or regulations concerning Medicinal Products and Medical Devices
- To apply high standards of occupational Health & Safety in the workplace to comply with company policy and procedures.
Knowledge and Experience
- Graduate with a degree in a relevant life science / engineering discipline, or an individual that has gained Vigilance / Risk Management / Design Control experience
- Knowledge and understanding of relevant GMP and Quality Systems standards and specifically with FDA Quality System Regulation, ISO 13485 and ISO 14971.
- Experience of working in a medical-related regulated environment.
- Experience of participating in National Competent Authority / Notified Body audits.
- Experience of project management with cross-functional teams
This is an urgent requirement so if it is of interest please apply immediately and contact Jamie.email@example.com to find out more.