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Senior Director of Quality Assurance

Manufacturing Jobs in Luton - Senior Director of Quality Assurance

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    15% bonus, 8K car
Job Description:

Senior Director Quality Assurance & Regulatory

£90,000-£100,000 plus bonus and range of benefits


Medical Devices

Job description

We are working with a global medical technology company who at an exciting and key time within their history have created a new position for a Senior Director for Quality Assurance & Regulatory Affairs.

This role has huge scope, working very much on a strategic level to drive change as the business grows with a focus on expanding their product portfolio and revenue.

You will be managing Quality and Compliance requirements for their Sales and Distribution sites across the European business; working in close partnership with stakeholders in the international sales organisation to promote a culture of quality in service delivery and continuous improvement.

If you have significant leadership experience working to global quality assurance requirements, specialising in post market regulatory requirements and are experienced in 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.
Experience and Qualifications:

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.