Quality Assurance Executive
About the role
Who are we?
Eon Dental is a high-impact medical devices & tech company growing at neck breaking speed. We are a team of over ~500 colleagues dedicated to making Eon Dental a leading global player in the clear aligner and dental services industry.
Eon Dental aims to deliver value to dentists and orthodontists worldwide by offering a superior quality product, dynamic pricing, treatment schemes as well as after-sales service and assistance.
Software and innovation are involved in all aspects of our product lifecycle; beginning from an engaging experience on the frontend applications that serves customers and dentists to robust backend solutions for process management and automation.
Our excitement about the vision and mission of the company has enabled us to foster a great culture and an exciting work environment that is based on building synergies and our team's exceptional talent to make our customers' experience outstanding.
Your Impact
The Quality Assurance Executive role reports to the Quality Assurance Lead. The role is responsible for executing assigned Quality Assurance activities in accordance with the Quality Management System (QMS), approved procedures, applicable regulatory requirements, and established timelines, supporting the effective implementation and maintenance of quality processes.
What You'll Do
- Execute assigned Quality Assurance activities in accordance with approved QMS procedures, SOPs, work instructions, ISO 13485, FDA requirements, and other applicable regulatory requirements.
- Maintain QA documentation and records, including controlled documents, forms, logs, reports, and other QMS records, ensuring accuracy, completeness, data integrity, and traceability.
- Prepare and update assigned SOPs, work instructions, forms, and other controlled QA documentation.
- Execute assigned validation, qualification, requalification, and change control activities and maintain associated documentation and records.
- Execute Computerized System Validation (CSV) activities to ens…