Quality Systems Manager

Quality Systems Manager- Medical Devices- Galway

Key Responsibilities:

  • Provide leadership and expertise in all aspects of Quality Systems. 
  • Ensure that the quality management system is managed, developed and implemented appropriate to the activities at the company. 
  • Develop and implement quality management strategies, policies and procedures.
  • Ensure the business is in compliance with all regulatory requirements related to quality management.
  • Day to day Leadership/Management of Quality Systems Team. Manage and develop the team through involvement, delegation, and regular reviews of performance.
  • Management of key quality systems elements such as the non- conformance system, customer complaints and CAPA, risk management, validation, quality audit (internal and external), document control, calibration, supplier quality.
  • Ensure the site is always “audit ready”, including preparation and successful achievement of all external audits from customers, regulatory bodies and third-party accreditation bodies.
  • Manage all quality related aspects relating to new production introductions.
  • Work with suppliers on quality related issues.  Ensure all dealings are professional and good relationships are maintained at all times.
  • Monitoring and reporting on trending metrics associated with the quality system.
  • Fulfil the role of management representative for the Quality Management system.
  • Actively participate in continuous improvement ideas, initiation, and implementation.
  • Lead quality related projects ensuring that they are delivered on time and within budget. 
  • To take on other duties which the Company may assign you from time to time. 
  • Keep your skills current and be conversant with the latest developments which are relevant to the Company’s business. 

Education and Experience:

  • Bachelor’s degree in Science, Engineering, Manufacturing or related field.
  • Thorough knowledge of medical devices quality systems (ISO13485/FDA).
  • A minimum of seven years of relevant progressive experience within a similar environment, with five or more successful years in a leadership position.
  • Strong leadership and people management skills.
  • Thorough knowledge of quality management systems and associated regulatory requirements (ISO 13485, FDA etc.).
  • Must be able to communicate at all levels of the organisation and with customers, suppliers and regulatory agencies.
  • Good interpersonal skills, team player, with a positive attitude in dealing with people. 
  • “Hands On” approach and mind set, with a passion for continuous improvement.
  • Must be innovative and be driven to implement change to systems and procedures.
  • Excellent analytical skills.  Ability to define problems, collect data, establish facts, and draw conclusions.
  • Demonstrable ability to achieve goals through collaborating, influencing and interaction at all levels across the business/function.

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Job Details

9 November 2023
Job ID: 8862

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