Austin Vita has an exciting opportunity for a Quality Manager with IVD experience to join our medical device client based in Cambridge at a pivotal time in their history as they look to progress their first product from Clinical to Commercial release globally. The company is intimate in size so will require you to "wear many hats" and be comfortable working in a very visible environment with lots of hands-on activities within the product operations team.
Objectives of the role:
Supporting product life cycle of IVD's with regards to all quality matters
Management of the Quality Management System
IVDR Responsible person (subject to appropriate experience and knowledge).
Act as the management representative for the ISO 13485 Quality Management System and take responsibility for Notified Body and Competent authority engagement.
Support in the preparation, maintenance and review of IVD product technical files.
Support in the implementation of the company's regulatory compliance strategy and development of new products.
Be a key player in driving continuous improvement of the companies QMS.
Maintain and Continually improve the Quality Management System
Support the Leadership Group by ensuring that company products comply with regulations in all registered territories.
Responsible for Product release to market.
Support in the preparation of IVD technical files.
Provide leadership at regulatory/customer inspections
Ensure timely support with regards to all QMS processes, to meet Product support and development deadlines.
At least 3 years working experience in a Quality Assurance role for an IVD manufacturer selling to the EU market.
Demonstrate a clear understanding of ISO 13485:2016 and the directives/regulations for CE marking. Must have had experience in managing a significant number of QMS elements.
5 years + QA experience working for an IVD manufacturer marketing product in EU, US and other regions.
Experienced leader/manager of ISO13485:2016 QMS.
Experienced in working/engaging with Notified bodies & regulators (i.e. lead inspections) and the preparation of high-quality regulatory dossiers.
Experience in Medical device software development.
You will be rewarded with a great salary and benefits, including; Private Health Insurance, Life Insurance and Pension.