- Quality Control Director - rapidly expanding scientific medical devices client
- Challenge of owning a Quality Control function for a manufacturing site
About Our Client
LumiraDx is a medical technology company developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions. Founded in 2014 by entrepreneurs with a successful track record in building and scaling medical diagnostics and health IT businesses, the company has major operations in the UK and the USA, and is supported by a global sales network, LumiraDx is a high growth organisation.
We are looking for proactive, experienced, focused and enthusiastic individuals who can make a significant contribution to the continued growth and success of our dynamic and forward-looking company.
- Create and manage metrics for Product quality, manufacturing quality and on market feedback for the product related to quality.
- Manage quality operations across sites and operate between manufacturing, packaging and distribution.
- Update QMS to include other global QMS requirements including WHO/CMDCAS as required based on product.
- Manage Product localisation and complaint release of products to the market
- Train the wider organisation in the importance of product quality
- Work with other group organisations to align on Quality for the business
- Support external audits for global certification purposes.
- Manage risk and validation activities for facility and processes, may include R&D sites.
- Manage the compliance of final product release.
- Manage complaints and PMS process
- Manage the QMS processes and infrastructure to ensure continued compliance and fitness for purpose for the business.
The Successful Applicant
Knowledge and experience of working to the appropriate quality and regulatory standards including ISO13485, FDA 21CFR Part 820
Experience of managing and hosting competent authority, notified body and customer audits.
Experience of working in an IVD or medical device environment or similar with minimum 5 years experience at Quality Manager level.
Previous experience of managing product release of medical device/IVD products.
Previous experience of aligning global company quality requirements and implementing resulting systems
Experience of managing and developing a high performing team
Experience of manufacturing and post launch IVD or medical device activities
Scientific background, minimum degree in Biology or Chemistry.
What's on Offer
Competitive remuneration package and a highly challenging visible senior management level role in a rapidly growing organisation.