We have a new opening for a Quality Systems Administrator to join a multinational MedTech company based in Roscommon. The successful person will be responsible for providing quality systems support for to all processes related to QMS. Assures that quality standards are maintained and assist with the implementation and compliance of the quality management program.
Quality Systems Complaints / CAPA / NCRs
- Support the recording, investigation and resolution of product complaints, product problems, or safety issues on our Trackwise system. Coordinate and document the Corrective Action Program to assure appropriate investigation and implementation.
- Execute internal audit schedule for area for which there is no direct responsibility and external 3rd party audits
- Run regular Complaint, CAPA, NCR and continuous improvement monitoring meeting
- Maintain KPI data around Complaint, CAPA, NCR and continuous improvement
- Provide QMS support to the Quality Engineering and Operations functions including Risk Assessment reviews and updates.
- Ensures that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented (Trackwise) and addressed by the Validation Project Team.
Environmental and testing
- Co-ordinate the environmental monitoring activities of the contractors
- Manage in process bioburden / Microbial ID monitoring
- Ensure all environmental metrics are maintained up to date
Regulatory Affairs Support
- Provide provision of documents support to RA for international country submissions
- Provide support for the maintenance of all RA documentation including Technical Master File
- IT or University or Technical college education level
Previous QMS work experience in a similar work environment is essential.
- Experience in working in High Volume Production Facility
- Strong computer skills - Change control management; design, process and system.
- Familiarity with ISO quality systems (ISO13485 – 21 CFR 820)
- Good customer relation skills
For a full job description and confidential discussion on this role please contact: Gillian Nicholson