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My client, a successful medical devices company in Galway are currently scaling their team due to new product development and have an opening for a Quality Manager to join their team.
The successful candidate will lead and support the quality team in quality assurance activities to support the business quality system.
Principal Duties and Responsibilities - 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, and internal policies and procedures. - 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. - Develop direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting performance reviews. - Support internal audit program for the business. - Serves as coach and mentor for new engineers
Required experience and qualificaions: - 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 - Demonstrate ability in selecting, interviewing, training, coaching, motivate, discipline, and direct people. - Extensive knowledge of the Quality System Regulation and Associated regulations and standards. - Requires hands on system and process validation experience
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales