Job Overview
Quality assurance expert sought to ensure the highest standard of Quality System support with focus on validations and non-conformances.
1. Develops and executes validation protocols and reports for new product introductions, and revalidations including IQ, OQ and PQ ensuring compliance with regulatory standards (ISO13485 etc.)
2. Analyzes validation data for report generation and makes informed decisions/recommendations based on this analysis.
3. Leads equipment qualification to ensure proper installation, and performance.
4. Ensures traceability and audit readiness of all validation activities for internal and regulatory audits/inspections.
5. Mentors colleagues to strengthen validation knowledge within the organisation.
6. Supports quality system maintenance to international standards ISO 13485, ISO 9001 and applicable regulations under the Medical Device regulation, including SOP creation and documentation revision within the quality management system.
7. Participates in customer and regulatory audits as required.
8. Product Development: Supports new product development, production trials, sampling and production runs of new materials and finished products as needed.
9. Monitors vendors and issues NCMRs where necessary and ensures problem vendors are identified and controls implemented to prevent problems.
10. Reports on relevant quality performance data and drives continuous improvement processes within the organisation through change control activities.
11. Manages investigation and closure of Validation Deviations, Non-conformances and CAPAs, including support of the investigation processes when not the owner.