About the Role:
We are seeking an accomplished Validation Professional to spearhead Quality Assurance activities, drive validation excellence, and ensure compliance with ISO standards.
* Design, execute, and analyze validation protocols for new product introductions and revalidations, guaranteeing full regulatory compliance (ISO 13485).
* Leverage statistical analysis to inform recommendations on validation results.
* Lead equipment qualification, ensuring optimal performance and correct installation.
* Maintain thorough documentation traceability and audit readiness for internal, customer, and regulatory audits.
* Support the maintenance and continuous improvement of our Quality Management System (ISO 13485), including SOP development and revision.
* Contribute to product development activities, such as trials, sampling, and production runs of new materials and products.
* Monitor vendor performance, address issues through NCMRs, and implement appropriate quality controls.
* Manage investigations related to validation deviations, non-conformances, and CAPAs.
Key Responsibilities:
* Validation Protocol Development
* Statistical Analysis and Recommendations
* Equipment Qualification
* Documentation and Audit Readiness
* Quality Management System Improvement
* Product Development Support
* Vendor Performance Monitoring
* Investigation Management
What We Offer:
This is a permanent position offering a world-class opportunity to further develop your career within a quality-focused environment.
You will play a key role in supporting our Quality Assurance team, driving validation excellence, and ensuring compliance with ISO standards.
A successful candidate will possess excellent communication skills, a strong analytical mind, and the ability to work independently in a fast-paced environment.
The ideal candidate will be detail-oriented, proactive, and passionate about delivering high-quality results.