Job DescriptionMy client is an exciting, forward-thinking medical device company based in the North East. Due to rapid expansion they are looking for a QMS Manager to join their thriving team. This is a great time to join this company as they are growing from strength to strength and developing some highly innovative medical device products that will change lives.
The role will be reporting to the Head of QA & RA and you will be responsible for the day-to-day running of the Quality Management System including authoring, revising and implementing quality procedures for the company. You will be required to facilitate the relevant company certifications and compliance as they near commercialisation phase.
Duties will include -
- Management of a small team of Quality Officers to ensure effective progression in line with company objectives
- Overseeing the compilation and maintenance of risk management files and take an active role in the risk management process
- Implementing quality systems that facilitate productivity, improve processes and guarantee efficiency
- Leading training sessions to ensure understanding and compliance from all employees
- Preparing, conducting and recording internal system audits and external supplier audits
- Regularly informing higher management of relevant regulatory and quality updates
- Communicating with the purchasing department to establish quality requirements from external suppliers
- Ensuring compliance with national and international standards and legislation eg. ISO13485
- Managing and implementing objectives and goals relating to the QMS
- Administration of the CAPA system including recording and investigating instances of non-conformance
- Identifying the need for quality training and delivering this training
Skills and experience required -
- Experience of working in a highly regulated industry (ideally ISO13485)
- Degree or equivalent in a Science or Engineering discipline
- Highly organised with the ability to motivate others
- Excellent communication skills
Candidates with a background in medical device industry would be preferred although this is not essential.