Quality Manager Medical Devices Galway

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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.comReal 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