- Location
- Wexford-Wexford, IE
- Closing date
- Today
- Source
- iCIMS
Description
Overview
Development, implementation, monitoring, and continual improvement of Quality Systems to ensure the highest levels of product quality and customer satisfaction while maintaining regulatory compliance.
The position is responsible for ensuring compliance with ISO9001, ISO13485, and applicable regulatory requirements within the company as they relate to the Quality Specialist role.
Responsibilities
The position is responsible for the ongoing development, implementation, maintenance and improvement of the quality management system.
The assessment of compliance with ISO9001, ISO13485 and applicable Good Manufacturing Practice regulations (21CFR820).
Documentation Management – review, distribution and archiving of documents.
Management of the Engineering Change Request (ECR) process to ensure effectiveness and compliance – QC agent, review meeting facilitator, follow-up completion.
Deviation Management - Coordination of the MS Deviation process and maintenance of the internal Temporary Manufacturing Deviation processes.
Prepare, conduct, report and follow-up on internal audits.
Generate, analyse and report data for relevant meetings.
Monitoring of regulatory changes including standards and guidelines
Management of the Consumables warranty claims process
Qualifications
Education:
Third level qualification would be advantageous.
Experience:
Experience of working in an ISO9001, ISO13485, cGMP environment. SAP experience desired but not essential.
Competencies:
Excellent attention to detail.
Good interpersonal, communication, report writing and problem solving skills are necessary requirements.
Ability to work independently and as a member of a cross-functional team, to multi-task and prioritise to meet high expectations and tight deadlines.
Travel (If Applicable): N/A