Quality Assurance Manager

  • Type: Permanent
  • Location: Limerick
  • Salary: Negotiable
  • Job Ref: QAM080119
  • Date Posted January 8, 2019

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.

Responsibilities:

  • 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.

Qualifications:

  • 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

More Details

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

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