A medical devices specialist requires a quality assurance professional to be responsible for reviewing Post market surveillance (PMS) data, ensuring that the safety, performance, and quality of existing products conform to established standards and are following all applicable global Quality System Regulations.
This is a new role within the Quality Assurance Business function and the key accountability's are:
- 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 complaint's 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.
Job Context / Key Challenges
- Ability to handle and resource plan multiple projects in a fast moving and evolving environment.
- Ability to operate computer equipment and associated software applications.
- Ability to effectively influence internal and external customers and suppliers.
- This role requires strong planning and analytical skills.
- This role interfaces internally primarily with personnel in the following functions: Design Quality, Post Market Surveillance, complaints management teams.
- This role may require interface externally with national competent authorities, notified bodies, 3rd party suppliers and service providers.
- This role requires the job holder to maintain currency of knowledge required to carry out activities and responsibilities effectively.
- This role will be expected to contribute to team performance through continuous improvement activities.
Knowledge and Experience (Knowledge and experience needed for satisfactory
performance of the job)
- 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
Please note that this is a remote working role the core hours are 8.30 -5.00pm
25k - 40k pro rata
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.