We are a market leading Medical Device Manufacturer and due to our continued growth, we have an exceptional opportunity for a Head of Quality Systems to join us.
 
Operating as a member of the Senior Quality Management Team your role will be to develop and grow the Quality Team with an emphasis on the implementation, development and maintenance of the QMS.
 
You will be responsible for up to 8 direct reports and up to 15 indirect reports
 
Key Responsibilities:
Grow and Develop the Quality Assurance Team
Drive the Quality Culture across the business
Establish and maintain the Quality Management System including implementation and maintenance
Monitor and maintain the non-conformity and CAPA system to ensure it works effectively and meets regulatory requirements
Monitor and maintain change control and internal/ supplier auditing systems to ensure they work effectively and meets regulatory requirements
To define and maintain the company qualification policy including new product design validation, equipment qualification, engineering change verification/validation from a Quality/ Compliance perspective.
Define and drive Risk Management activities which add value throughout the lifecycle of the product/ process
 
To be successful as our new Head of Quality Systems, you will need to have a strong background in Medical Device Manufacturing and proven leadership experience is an essential requirement.
 
Knowledge, Skills and Experience Required:
Extensive and proven experience within a Medical Device Manufacturing Environment
Proven experience within a Senior Quality Assurance Leadership Role
Proven Leadership skills and experience
Knowledge and Experience of the implementation, development and maintenance of Quality Management Systems in a Medical Device Manufacturing Environment.
Knowledge of ISO 9000, 13485, CFR 211 and 280 and Part 11 requirements. Knowledge of ICH Q9 and ICH Q10.
Demonstrable competencies of strategic influencing (of key stakeholders/leaders), initiative, and leadership.
Experience of product risk assessment tools (i.e. FTA, DFMEA) and design control.
 
If you have the necessary skills and experience to be successful in this role, please apply now or contact Kris Holmes on 01189 239 234.