Quality Manager Medical Devices Galway West of Ireland
Quality Manager Medical Devices opportunity Galway, West of Ireland
A medical devices company in Galway is recruiting a Quality Manager.
Successful Quality Manager will be responsible for managing the identification, implementation, and support of quality assurance activities to support the business quality system. Provides technical and administrative guidance to Quality Assurance, Manufacturing, and suppliers of raw materials and finished medical devices. Required to communicate effectively with internal employees, regulators, and suppliers/consultants and contractors. Committed to corporate goals of customer satisfaction and continuous improvement. Direct reports include Senior Engineers, Quality Engineers, and QA Technicians.
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, and 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 company 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.
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
Lead and motivate team members through feedback and stretch assignments. Establishes and maintains high levels of credibility. Collaborates effectively across the organization, leverages resources from other parts of the organization to build commitment and achieve results.
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
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.
People management experience
For immediate telephone interview for this Quality Manager opportunity in Galway please email CV to email@example.com or for further information call Bimi on 087 1186820