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.
- 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