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Director of Quality Assurance- Medical Devices

Manufacturing Jobs in Luton - Director of Quality Assurance- Medical Devices

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    15% bonus, 8K car
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Director- Quality Assurance- Sales and Distribution Sites
£85,000-£95,000 plus bonus and range of benefits
Medical Devices
Job description
We are working with a global medical technology company specialising in a range of therapy areas with a recognised portfolio or turn-key solutions.
With significant restructuring and growth in their international markets they are looking for a Director of Quality Assurance to manage an established team overseeing their Quality and Compliance requirements for their Sales and Distribution sites.
The Director of Quality Assurance is very much a role focused on change management and shaping processes from the ground up at a pivotal time. The position therefore presents an exciting challenge for the right individual.
You will strategically drive Quality and Regulatory Compliance in the Northern European Region to ensure that service delivery meets customer quality expectations.
With this being responsible for Quality Assurance across distribution sites you will be working in collaboration with the international sales organisation to identify and lead on the implementation of QA strategies, promoting a culture of quality in service delivery, continuous improvement and minimising business risks within the commercial arm of the business.
If you have significant leadership experience working to global quality assurance requirements, specialising in post market regulatory requirements and an appreciation of sales and service settings within the medical device arena please get in touch.
Role Responsibilities:
" Lead the regional Sales and Service Quality organization in implementing local quality system compliant programs, including a robust CAPA system
" Establish and maintain ISO 13485, where applicable
" Build a strong Quality Management System
" Build and strengthen the quality assurance team.
o Bachelor's degree in science or relevant technology discipline
o Extensive experience in Quality and/or Regulatory management
o Previous background and experience in medical device quality
o Strong knowledge and experience in global quality requirements, with an emphasis on Europe and the MDD
o Successful interactions with global Quality and Regulatory teams
Other essential requirements:
o Travel: The role requires travel within Europe so the ability to travel within the UK and abroad with overnight stay is essential.
If you are looking for an opportunity to shape strategy at the top level but also to build systems from the ground up at a pivotal time in company's history this could be the role for you.
Please send your CV and contact James Powell of TXM Recruit.
("quality assurance" or "iso 13485" or "iso13485" or "post market surveillance" OR "quality management system" OR "regulatory affairs")
TXM Recruit is an equal opportunities employer. If you have any specific requirements or require assistance or reasonable adjustments to be made for you during the selection process due to disability or long-term health condition, we will do our best to assist you.

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