- Entry level
- No Education
- Salary to negotiate
- ELSTREE HERTFORDSHIRE
PE Global is currently recruiting for a Quality Engineer (Med Device Regulations) for our leading multi-national Med Device client based in Elstree (12 months contract).
The candidate will work with the Elstree Product Design Owner (PDO) in performing tasks related to regulatory compliance, change control, design control, and risk management for Advanced Surgery products produced.
POSITION DUTIES & RESPONSIBILITIES:
- Support the PDO in fulfilling requirements for regulatory compliance, design control and risk management activities for Orthobiologic products manufactured at Elstree
- Lead activities required in the design and development assurance and documentation to maintain regulatory compliance, particularly for the new European Medical Device Regulation (MDR).
- Review and execute regulatory gap assessments against existing and new Regulation.
- Maintain and remediate Design History Files and Risk Management files for Elstree products
- Generate and manage work flow for appropriate change control documentation.
- Project management of projects related to design assurance, risk management and DHF remediation.
- Support the PDO in gathering information from Subject Matter Experts (SMEs) and technical resources for complaint investigations, change control, and regulatory submissions
EDUCATION & EXPERIENCE REQUIREMENTS:
- Bachelor's degree in a scientific or engineering discipline with 1-5 years’ work experience or MS with 2 years’ experience
- Previous experience as a Quality Engineer would be ideal.
- Experience working in regulated industry (medical devices, drugs, biologics) is preferred.
- Knowledge and experience working with medical device regulatory requirements, design control, change control, and risk management is highly desirable.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Amparo on +44 0203 86 86 203 or alternatively send an up to date CV
Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert.
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