Our client, a leading medical device company based in Limerick, currently has an opportunity for a Quality Assurance Manager to join their team. This is a full time, permanent position offering an excellent salary and benefits package.
Ensure that the QMS meets all relevant regulations including ISO13485, 93/42/EEC, Medical Device Directive, FDA 21 CFR Part 820 Quality System Regulations, FDA 21 CFR Part 11 Electronic Records/Electronic Signatures and FDA 21 CFR.
Ensure compliance of the QMS with global QA policies, procedures and direction.
Manage the team with overall responsibility for ensuring that the QMS is implemented, maintained and understood by all employees, whilst meeting all relevant external regulatory requirements.
Develop direct reports and wider team through ongoing coaching and mentoring for continued employee growth and team succession planning.
Maintain overall responsibility for the customer complaints process, ensuring that customer complaints are dealt with appropriately by the Customer Relations team and transferred to the relevant manufacturer within agreed timelines.
Monitor trends and analyse key Quality Metrics.
Manage quality costs and ensure a full understanding of departmental expenditure and budget.
Act as a Continuous Improvement advocate, working with the Continuous Improvement Team, driving Continuous Improvement philosophy and practices
Designee for Global Director, Quality Assurance, Customer Support and Delivery for Quality related processes.
7-plus years of applicable experience in a quality environment
Minimum of 3 years’ management experience leading Quality professionals.
Bachelor’s degree or equivalent in Quality, Science or Engineering.
Knowledge and experience of ISO13485 and the MDD
Knowledge and experience of FDA, GMP, and International Quality
Knowledge and experience of all aspects of Quality Assurance, Quality Engineering and Regulatory Affairs.
Excellent communication and inter-personal skills.
Excellent analytical, problem solving and organisational skills
Willingness and availability to travel on company business.
For more information on this position and a full job spec please call Lee-Ann Enright on 061336136 or apply online and a member of the Harmonics team will be in touch