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Quality Systems Director

Job Title: Quality Systems Director
Contract Type: Permanent
Location: Galway
REF: 83056
Job Published: over 2 years ago

Job Description

Quality Systems Director
Our client, a leading medical device company in Galway, are looking to recruit a Quality Systems Director. The successful candidate will report to the VP of Operations & Supplier Quality. The Quality Systems Director will be responsible for promoting continuous improvements and instilling organisational leadership.

  • Providing overall Quality leadership for the site by establishing a clear vision and strategic direction for Quality that assures customer satisfaction, regulatory compliance and drives continuous improvement
  • Contribute to overall site strategic and tactical direction as a member of the Senior Leadership Team
  • Provide critical input and influence as a staff member of multi-site operations quality team
  • Leadership of the site quality function ensuring the development, engagement and retention of a strong pipeline of Talent to ensure capability in line with current and future needs.
  • Establish the site quality plan and objectives, ensuring all activities are conducted in accordance with the requirement of the Quality System and applicable external regulatory body requirements.
  • Champion the First Time Quality Principle to improve our internal and external product quality performance
  • Participate in the innovative application of business process improvement opportunities across site
  • Leverage the cell operating system and other Lean principles to improve effectiveness and efficiency of all quality processes and services
  • Participate as member of the Cardiac and Vascular Group site quality leaders forum to influence the development and improvement of the shared quality system
  • Ensure that the quality system assures product quality and regulatory compliance by predictably and consistently detecting and correcting deficiencies
  • As designated management representative, ensure execution of site quality management review
  • Ensure effective preparation and execution of all external regulatory agency site inspections and communications
  • Influences the product development process through the core team and has responsibility for effective transfer validation to operations to assure product quality and regulatory compliance
  • Ensure post market surveillance of site products is operating effectively through business partners.
  • Manages Quality Assurance systems and programs to ensure acceptance and monitoring of material, equipment and environment used to manufacture product from plant through sterilisation and release to distribution

  • Clear understanding of Quality System Regulations (QSR), design control, ISO 9001 standards, ISO 13485:2003, European MDD regulation and Japan PAL regulation
  • Knowledge of FMEA, health hazard analysis, reliability analysis, process validations, software validations, DOE, SPC, process capability techniques and other quality tools.
  • Must have an in-depth understanding quality systems, business process improvement tools, manufacturing and processing principles.
  • Bachelor?s degree in Engineering, Sciences or related medical/scientific field is required. Masters preferred.
  • 10+ years? relevant industry experience with at least 5+ years people management experience
  • Experience in medical device or related industry.
For further information on this Quality Systems Director role in Galway please contact Nicola O?Connell on 091730022 /
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