Quality Operations Manager
The Quality Operations Manager plays a pivotal role in site process improvement activities, leading the Quality Operations Team onsite and serving as the central point of contact for key stakeholders.
Key Responsibilities:
* Provide support for relevant ISO Quality Systems.
* Ensure adherence to all internal, external, and regulatory requirements.
* Become a key member of the Quality Leadership Team.
* Support production personnel in continuous improvement activities (Six Sigma).
* Lead the Quality Engineering Team, managing and developing team members through involvement, delegation, and regular performance reviews.
* Manage quality systems elements relating to direct production support, such as the non-conformance system, incident reporting system, and customer complaint analysis.
* Liaise with external customers and ensure compliance with regulatory commitments.
* Maintain documentation according to regulatory requirements.
Requirements:
* Third-level qualification in an Engineering or Science Discipline.
* Postgraduate qualification in a related area is advantageous.
* 5+ years of experience in an ISO 9001/2000 or ISO 13485 environment, preferably in Medical Devices/Pharmaceutical Industry.
* 3+ years of supervisory experience.
* Experience in CAPA system management, FDA requirements, and process validation.
* Familiarity with Statistical Process Control and Six Sigma methodologies (Greenbelt Certification is advantageous).
Preferred Skills:
* Quality Operations
* People Management
* Medical Device
This is a fully onsite role. The ideal candidate must have fluent English written and verbal skills and be willing to relocate to the site in South Dublin.