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Quality Systems Administrator

  • Sector: Engineering
  • Contact Email: gillian.nicholson@collinsmcnicholas.ie
  • Job Ref: 18303

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.

Responsibilities:

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

Validation support

  • 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

Requirements:

EDUCATION:                    

  • IT or University or Technical college education level

EXPERIENCE:                    

Previous QMS work experience in a similar work environment is essential.

COMPETENCIES REQUIRED:                    

  • 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

090-6450665

gillian.nicholson@collinsmcnicholas.ie