Quality Validation Engineer

Our client based in Mildenhall is looking for an experienced Quality Validation Engineer to join their team.

We are seeking candidates who have at least 3 years of experience within the medical sector and a full understanding the validation and verification lifecycle for new medical devices.

This is an exciting opportunity to join a reputable company offering future training and development.

Please note that this role does involve regular travel to China for a few weeks at a time so you must be flexible to travel.

Who are we?

We are Busy Bee Recruitment, an awarding-winning recruitment agency supplying both temporary and permanent staffing solutions throughout the UK to our wonderful client base.

Duties:

• General all documentation relating to the validation of medical and non-medical devices, products, components or systems..
• Generate documentation in line with ISO 13485, FDA CFR part 21, MDR and other medical device regulatory requirements.
• Generate documentation in line with ISO 9001 requirements and other non-medical regulatory requirements.
• Perform tooling, equipment, system and manufacturing validation qualification for both medica and non-medical products.
• Lead validation activities either on-site. remotely with regards to worldwide site and occasional travel.
• Lead validation review board, periodic re-validation activities and maintain relevant standard operating procedures, protocols.

What we are looking for:

• A full understanding of the validation and verification lifecycle, V-Model and GHTF Process Validation.
• Self-disciplined and motivated to be able to work as an individual and as part of a team.
• Strong problem-solving skills and techniques, including root cause analysis.
• Strong statistical analysis and Cpk/Ppk understanding.
• A history of efficiency improvements.,
• A working knowledge of Microsoft Office programs.
• 3 years industry experience in the medical sector

So, are you ready for your next job? Hit on the apply button today

If you have not received a response within 3-5 working days, unfortunately your application has been unsuccessful. Busy Bee Recruitment Ltd is acting as an Employment Agency for this Permanent vacancy.

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