Quality Manager Medical Devices (Galway)

Galway, Full Time

Our client, a global medical device manufacturer in Galway, is looking for a Quality Manager.

The successful candidate will provide technical and administrative guidance to Quality assurance, be committed to corporate goals of customer satisfaction and continuous improvement.

Job Description:

  • Manage all quality control activities relating to customer complaint and production including audits, inspections and process validations.
  • Ensures suppliers, contractors and consultants performing systems work related to quality systems comply with regulations, standards, and internal company policies and procedures.
  • Responsible for device history review, product release, and site meteorology program
  • Support and ensure compliance of quality systems to the QSR, applicable regulations, internal procedures, and internal audit programs for the business.
  • Lead cross- functional teams in product and process development, while serving as a coach and mentor for new engineers.
  • Translate departmental goals into individual objectives for direct reports, provide resources, including the assignment of trained personnel for performance of work and assessment activities to meet requirements.
  • Develop direct reports by ensuring appropriate training, apply progressive disciplinary action as appropriate and conduct performance reviews.

Job Requirements and Competencies:

  • Minimum of 5 years’ experience in quality engineering or regulatory compliance role.
  • Degree in manufacturing or Quality Engineering discipline
  • Related Bachelor’s degree in another field
  • Experience in people management or a leadership position
  • Extensive knowledge of the Quality System Regulation and Associated regulations and standards.
  • Ability to collaborate effectively across the organization, leverages resources from other parts of the organization to build commitment and achieve results.
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