Quality Manager Medical Devices (Galway)
Galway, Full Time
Our client, a global medical device manufacturer in Galway, is looking for a Quality Manager.
The successful candidate will provide technical and administrative guidance to Quality assurance, be committed to corporate goals of customer satisfaction and continuous improvement.
- Manage all quality control activities relating to customer complaint and production including audits, inspections and process validations.
- Ensures suppliers, contractors and consultants performing systems work related to quality systems comply with regulations, standards, and internal company policies and procedures.
- Responsible for device history review, product release, and site meteorology program
- Support and ensure compliance of quality systems to the QSR, applicable regulations, internal procedures, and internal audit programs for the business.
- Lead cross- functional teams in product and process development, while serving as a coach and mentor for new engineers.
- Translate departmental goals into individual objectives for direct reports, provide resources, including the assignment of trained personnel for performance of work and assessment activities to meet requirements.
- Develop direct reports by ensuring appropriate training, apply progressive disciplinary action as appropriate and conduct performance reviews.
Job Requirements and Competencies:
- Minimum of 5 years’ experience in quality engineering or regulatory compliance role.
- Degree in manufacturing or Quality Engineering discipline
- Related Bachelor’s degree in another field
- Experience in people management or a leadership position
- Extensive knowledge of the Quality System Regulation and Associated regulations and standards.
- Ability to collaborate effectively across the organization, leverages resources from other parts of the organization to build commitment and achieve results.