Our client is an innovative startup company that develops electrotherapy
devices for the treatment of certain types of brain tumours. Our clients are
attempting to use this technology to slow tumours growth with the possibility
that this might extend the lives of patients.
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 client’s 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.
* 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 includi
third party external audits, such as preparation of relevant QMS
* 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
* Manage the quality management systems and facilitate internal audits to
ensure effective quality control procedures are implemented and are
* 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
* Support the activities involved in the regulatory management of post
market surveillance and vigilance activities in compliance with the MDD.
* Hold a BSc or Masters degree in life sciences, engineering or related
* 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
* 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
Apply to this job.
Think you’re the perfect candidate?
Job ID: 212427471
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