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 ImpactThe 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 ensure system compliance with applicable regulatory, data integrity, and QMS requirements.
- Support internal audits by preparing documentation, collecting evidence, participating in audit activities, and following up on assigned actions.
- Support external audits and regulatory inspections by preparing requested documentation and evidence.
- Support assigned CAPA and nonconformity activities, including data collection, investigation, root cause analysis, corrective actions, effectiveness checks, and documentation.
- Support quality investigations by collecting relevant information, documenting activities, and following up on assigned actions.
- Monitor assigned manufacturing and distribution activities for compliance with approved specifications, procedures, and QA requirements, and report identified deviations or quality concerns.
- Support supplier quality activities by maintaining supplier records, collecting required documentation, tracking quality issues, and following up on assigned actions.
- Maintain QA-related training records and support the completion of required quality training activities.
- Adhere to quality standards and safety procedures in accordance with company guidelines and local regulations.
- Take appropriate action in relation to hazards and work-related issues and escalate as needed to ensure prompt and effective resolution.
- Perform other job-related tasks as assigned by the line manager to support organizational objectives.
What To Bring
- * Bachelor’s degree in Pharmacy, Engineering, Chemistry, Biology, or a related scientific field.
- 0–2 years of experience in Quality Assurance, Quality Management, or a related function.
- Experience in a regulated industry, such as medical devices, pharmaceuticals, biotechnology, or other regulated manufacturing environments, is preferred.
- Strong foundation in Quality Assurance and Quality Management System (QMS) principles.
- Good understanding of documentation and records control, with a strong focus on accuracy, data integrity, and traceability.
- Basic knowledge of CAPA and nonconformity management.
- Hands-on experience in validation and qualification activities, including equipment, processes, and computerized systems (IQ/OQ/PQ/CSV).
- Familiarity with ISO 13485 and FDA Quality System requirements is preferred.
- Exposure to internal auditing, quality risk management, and supplier quality activities is preferred.
- Strong attention to detail and ability to maintain accurate and complete quality documentation.
What We Offer
- * Great culture and growth opportunity
- The chance to personally impact Eon’s customer experience
- Push your boundaries working with highly motivated and cross-functional teams
Interested?Then apply for this position by clicking on the apply button. All applicants must send an updated CV in English.
