Quality Assurance Specialist
This is an exciting opportunity for a skilled Quality Assurance specialist to join our team and play a key role in ensuring compliance with ISO standards and regulatory requirements.
The ideal candidate will have experience in supporting Quality Assurance activities, driving validation excellence, and ensuring the highest level of product quality.
* Write and execute validation protocols and reports for new product introductions and revalidations, ensuring full regulatory compliance (ISO 13485, etc.).
* Conduct data analysis on validation results and provide informed recommendations based on statistical evaluation.
* Lead the qualification of new and existing manufacturing equipment, ensuring correct installation and optimal performance.
* Maintain full traceability and audit readiness of all validation documentation for internal, customer, and regulatory audits.
* Support the maintenance and continuous improvement of the Quality Management System (ISO 13485, ISO 9001), including creating and revising SOPs.
* Collaborate closely with cross-functional teams to ensure seamless execution of quality-related activities.
* Identify areas for process improvement and implement changes to enhance overall efficiency and effectiveness.
Key Responsibilities:
• Validation and verification of products and processes
• Data analysis and reporting
• Equipment qualification and maintenance
Requirements:
• Bachelor's degree in a relevant field (e.g., engineering, science)
• Minimum 3 years of experience in a similar role
• Strong knowledge of ISO 13485 and ISO 9001 standards
What We Offer:
A dynamic and supportive work environment
Opportunities for career growth and professional development
Competitive salary and benefits package