Quality Control Operations Manager
2 weeks ago
Job Title: Quality Control Operations Manager
This position involves leading and coordinating Quality Control activities, ensuring compliance with ISO/IEC 17025 standards.
The successful candidate will possess a relevant third-level qualification and working knowledge of ISO 17025, GDocP, and experience in ISO-regulated environments.
A proven track record in managing projects and leading teams is essential, as well as the ability to conduct effective audits and travel if necessary.
Familiarity with IVDD/IVDR regulations, Irish EHS legislation, validation practices, and QMS software systems is also required.
Key Responsibilities:
Oversee the implementation and maintenance of the ISO 17025 Quality Management System to ensure full compliance, audit readiness, and continuous improvement across all QC laboratory activities.
Coordinate and supervise all QC testing operations including scheduling, resource allocation, staff development, and ensuring KPI targets and company objectives are met.
Manage laboratory documentation and compliance processes including SOP updates, deviations, CAPAs, change controls, and product/batch release based on verified test results.
Act as primary QC representative in audits and reviews supporting timely closure of non-conformances, managing internal and external audit activities, and reporting lab performance trends.
Develop and implement training programs to enhance staff competency, validated methods, reliable equipment, and seamless collaboration with QA, Production, and customers.
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