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Quality Manager

Quaity Manager - Galway - Medical Devices

 

Quality Manager required for a very busy Medical Device multinational. This role is to backfill someone promotes into a Senior Manager role, .

People Management and Medical Devices experience is essential.

 

Apply today for more details, or reach out to us for a discreet conversation around this role.

 

Role:

  • Determine and define quality assurance requirements from review of engineering drawings and/or specifications, industry standards, government specifications or other applicable source documents.
  • Manage quality control activities related to production including incoming inspections, audits, process validations.
  • Ensures compliance of quality systems to the QSR, other applicable regulations/standards, and internal procedures, including but not limited to validation.
  • Ensures suppliers, contractors and consultants performing systems work related to quality systems comply with regulations, standards.
  • Develop and administer effective data collection and reporting system to meet regulatory requirements and management information needs.
  • Actively monitors data sources and collects data where necessary to identify process requirements and significant process improvement opportunities.
  • Leads implementation of quality improvement projects.
  • Manage quality control investigation activities related to customer complaints.
  • Monitor, report out on and drive improvement in corporate Quality metrics
  • Responsible for device history record review and product release.
  • Provides resources, including the assignment of trained personnel for performance of work and assessment activities to meet requirements. 
  • Develop direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting performance reviews.
  • Translate department goals into individual objectives for direct reports.
  • Support internal audit program for the business.
  • Responsible for site metrology program
  • Leading cross-functional teams in product and process development
  • Serves as coach and mentor for new engineers

Education/ Experience Requirements – 

  • Degree in Manufacturing or Quality Engineering discipline, or 
  • Bachelor’s degree in another field plus a minimum of 5 or more years’ experience in a quality engineering or regulatory compliance role.
  • Suitable people management experience