Our client is a global medical technology company with sites across the UK and US. They focus on developing and manufacturing diagnostic care solutions and also take these products to market and commercialisation. They are currently experiencing growth and expanding their business so will be recruiting proactive and enthusiastic people to support the growth of the business, one of the roles they are recruiting for initially is a Quality Director.
The role is to be responsible for the Quality Operations for the business across multiple sites, you will work closely with the Quality and Regulatory Directors across the business to drive improvements and implement requirements to meet global business needs. You will be responsible for activities such as the improvement and maintenance of the product quality of the product and the QMS components, facility and process validation, product release and complaints handling are included within this role. This role will be responsible for line management of Operations Quality Managers and Senior Quality Engineers.
- Work at strategic level and understand the business and make decisions that affect multiple sites, assessing impact of quality across multiple sites.
- 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, cartoning and distribution sites .
- Work with QMS director and Update QMS to include other global QMS requirements including WHO/CMDCAS as required based on product release
- Manage Product localization and complaint release of products to the market
- Train the wider organization in the importance of product quality
- Work with other organizations 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 relating to operations quality processes to ensure continued compliance and fitness for purpose for the business.
- Highly motivated individual that can demonstrate flexibility and a can do attitude.
- Ensures positive, productive and proactive relationships with a range of internal and external key stakeholders.
- Self driven, takes ownership and demonstrates high levels of personal accountability, and is motivated to complete the goals and objectives
- Can listen and present effectively, providing progress updates and feedback on a regular basis
- Ability to plan and organise work in accordance with the overall objectives and required timelines
- Demonstrates the ability to solve problems under conditions of uncertainty and ambiguity and is able to think strategically in times of pressure to drive toward the best solutions
- Knowledge and experience of working to the appropriate quality and regulatory standards including ISO 13485, FDA 21CFR part 820
- Experience of working on an IVD or medical device environment with a minimum of 5 years experience quality manager level.
This is an excellent opportunity to join a very success and expanding company with global exposure