Senior Quality Assurance Specialist

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 Senior Quality Assurance Specialist role is based in Jordan and reports to the Quality Assurance Lead. The role is responsible for executing and maintaining quality assurance and validation activities to ensure full compliance with applicable regulatory requirements (e.g., ISO 13485, 21 CFR Part 11). The role ensures the validated state of products, processes, and systems, supports audit readiness, drives effective resolution of quality issues through CAPA, and contributes to continuous improvement initiatives, safeguarding product quality, data integrity, and overall compliance. What You'll Do Execute validation and qualification activities for equipment, processes, products, and computerized systems (IQ/OQ/PQ/CSV), ensuring compliance with approved protocols and applicable regulatory requirements, including 21 CFR Part 11. Maintain the validated state by managing change control inputs, requalification activities, and data integrity requirements, ensuring full lifecycle traceability in accordance with ISO 13485. Implement and maintain QMS processes, including documentation control (creation, review, approval, distribution, and archiving), SOP development, and training coordination to ensure compliance with internal and external requirements. Conduct internal audits and support external audit readiness, including addressing findings, driving CAPA activities, and ensuring effective closure of nonconformities. Investigate quality issues, deviations, and nonconformities, perform root cause analysis, and collaborate cross-functionally to implement corrective actions and improve process performance. Establish and monitor quality control and acceptance activities across manufacturing and distribution to ensure product compliance with specifications and regulatory standards. Support supplier quality activities, including evaluation and auditing of suppliers and collaboration with procurement to resolve quality issues and drive improvements. Contribute to regulatory activities by providing QA input to product registrations and maintaining awareness of applicable regulatory updates. Drive continuous improvement initiatives using quality tools and methodologies (e.g., risk-based approaches, Six Sigma), enhancing product quality, system reliability, and operational efficiency under QA leadership. Adhere to the quality standards and safety procedures as per the company guidelines and local regulations. Take appropriate actions in relation to any hazards and work related issues, and escalate as needed, in order to ensure prompt and effective resolution. Perform other job-related tasks as assigned by the line manager, in order to ensure the fulfillment of organizational objectives. What To Bring Bachelor’s degree in Chemistry, Biology, Pharmacy, Engineering, or a related field. 4–6 years of experience in validation and CSV within regulated industries (medical devices, pharmaceuticals, biotechnology, or FMCG). Strong understanding of QMS, GxP, validation, and CSV processes. Hands-on experience with ISO 1