A Major Medical Devices Company in Tullamore, County Offaly, Ireland is seeking to recruit a suitably qualified person for the following post:
The QA Specialist will be responsible for
QMS: QMS Implementation - Includes:
Review of corporate procedures for completion within the local QMS
Co-ordinate review of QMS procedures
Leading meetings to ensure that key site metrics are delivered, updated and reported as required
Update on KPI's both internally and externally as required
Ensure Audit QMS at all times
Lead complaints improvement process - use of complaint defect codes to trend data and
Manage trending, investigation and corrective actions from complaint data
Support technical assessments as required
Review of complaint investigations
3rd Party Inspections
Support the preparations of the site for 3rd party QMS audits including support to the back room team
Support and present as required to 3rd party auditors
Maintain database to ensure audit ready at all times.
Support Electrical safety audits as required
Manage the routine QMS process including
Internal Audits - schedule, execution and follow up activities
CAPA review board - schedule, execution and follow up
Document Control support
Development and Continuous improvements
Engineer/Science qualification (Minimum BSc or BEng) with minimum of 2 years working within QA in a multi-national medical devices manufacturing environment.
Excellent working knowledge of ISO 13485 and 21CFR820 and MDSAP program, along with exposure to other regulations. Working familiarity with IEC 60601 a distinct advantage.
Experience in dealing with external Regulatory bodies to manage certification and audit program including following up actions of the Quality Management System
Experience in working within a CAPA program, and other quality management systems and
Experience in internal auditing to QSRs and ISO 13485 requirements.
Experience in Six Sigma / lean techniques and statistical analysis a distinct advantage
Renumeration: An excellent Salary/Benefits on offer and negotiable
Please forward your CV in word format to:
Informal inquiries to Christy O'Hara on 087-9473404 or 00353 879473404 if outside Ireland