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Medical Device QA/RA Manager - Permanent - Cheshire - Cheshire

Medical/Pharmaceutical - Quality
Ref: 395 Date Posted: Thursday 17 Sep 2020
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Our client is an innovative startup company that develops electrotherapy devices for the treatment of certain types of brain tumours. Several studies have suggested that electrical stimulation can be used to interfere with cell division. Our clients are attempting to use this technology to slow tumours growth with the possibility that this might extend the lives of patients with brain tumours.

They are seeking an experienced Quality Manager to join their team on a permanent basis. The post holder will focus on the institution and implementation of an ISO13485 quality management system and will support the regulatory and quality management requirements for market approval of an innovative class III medical device.

Our clients approach combines the cutting edge of biology, advanced materials, and precision engineering. They are a rapidly growing company with a small, passionate team with a range of scientific backgrounds.

This is a rare opportunity to join an early stage but rapidly growing MedTech company at a senior level and to share in their success as it grows.

As a member of this team, you will be responsible for making decisions that have an enormous impact on the future of their business from day one and be expected to lead quality management programs with significant autonomy. You will also be expected to contribute to the wider regulatory strategy and other aspects of the technology development.

Working alongside their technical and clinical team members, you will also work with their numerous sub-contractors and collaborators and their highly experienced external Quality Consultant, who will be able to provide mentorship, technical training and support in implementing their ISO 13485 quality management system.

Responsibilities would include:

  • Implement/monitor processes and procedures to ensure the companies QA measures align with regulatory standards
  • Manage the company’s quality management systems for ISO 13485 including third party external audits, such as preparation of relevant QMS documents.
  • Take the lead role in the assembly of the companies Technical File for submission to healthcare regulatory agencies internationally.
  • Provide guidelines, support and training to staff in the operation of quality assurance and control methods to ensure that the companies policies and up to date and meet the requirements of international regulators
  • Manage the quality management systems and facilitate internal audits to ensure effective quality control procedures are implemented and are continuously improved
  • Work closely with the technical and production team to improve production processes and quality control, in order to obtain CE mark
  • Act as senior point of contact for compliance issues and instigate corrective action internally and externally when non- conforming issues arise
  • Support the activities involved in the regulatory management of post market surveillance and vigilance activities in compliance with the MDD.

Successful candidates would:

  • Hold a BSc or Masters degree in life sciences, engineering or related disciplines.
  • Have 3+ years of experience of operating within an ISO13485 QM system in a MedTech, pharmaceutical or biotech company.
  • Have experience in internal and external quality auditing
  • Have an ambition to step up in the future and take the lead in all aspects of the company’s quality management and regulatory affairs activity.
  • Have a rigorous approach to work with a strong eye for detail
  • Have strong communication, interpretation, and presentation abilities
  • Be passionate about technology, healthcare and entrepreneurship
  • Be an excellent written and oral communicator
  • Be driven, motivated and organised
  • Be a team player with demonstrable leadership potential
  • Be a quick learner willing to throw themselves into new challenges

 

 

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Our degree qualified consultants have specialist knowledge of the UK medical engineering consultancy job market. We have a successful track record in finding the best candidates for our clients who know and trust Medical Engineers to understand their business requirements.

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