Who are we?
Eon Dental is a high-impact medical devices & tech company growing at neck breaking speed. We are a team of over 300 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 serve 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’ experiences outstanding.
Your Impact
The Quality Assurance Specialist is based in Jordan and will be working from the Factory located near Queen Alia International Airport, they will be reporting to the Quality Assurance Supervisor and will be responsible for ensuring that all aspects of the company's quality management system (QMS) meet regulatory requirements and industry standards. This role focuses on maintaining and improving product quality, overseeing quality control processes, and supporting continuous improvement initiatives within the organization.
What You'll Do
- Develop, implement, maintain, and continuously improve the QMS in accordance with relevant standards and regulations (e.g., ISO 13485, FDA QSR).
- Conduct internal audits and assessments to ensure compliance with QMS procedures and identify areas for improvement.
- Drive corrective and preventive action (CAPA) processes to address non-conformities and improve quality system effectiveness.
- Establish and maintain quality control processes and procedures to monitor product quality throughout the manufacturing and distribution processes.
- Perform batch record review, product release activities, and ensure adherence to specifications and standards.
- Investigate and resolve quality issues and deviations, collaborating with cross-functional teams as necessary.
- Ensure that products and processes comply with applicable regulatory requirements and standards.
- Support regulatory affairs in submissions and provide quality assurance input for product registrations and approvals
- Manage document control processes, including document creation, review, approval, distribution, and archiving.
- Conduct training programs related to quality assurance procedures.
- Assist in evaluation and auditing of suppliers and contractors to ensure they meet quality and regulatory requirements.
- Collaborate with procurement and supplier management teams to resolve quality issues and drive supplier improvement initiatives.
- Participate in continuous improvement projects aimed at enhancing product quality, operational efficiency, and customer satisfaction.
- Utilize quality tools and methodologies (e.g., DMAIC, Six Sigma) to analyze data, identify root causes, and provide support in implementation of effective solutions.
- 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
- 1-4 years of experience in Quality Assurance & Regulatory Affairs.
- Strong knowledge of quality management systems (QMS) and regulatory requirements.
- Experience in validation of machines and processes (IQ, OQ,PQ).
- Experience in conducting audits.
- Knowledge of ISO 13485 and 9001 standards is preferred.
- Good Practices (GXP) knowledge is preferred.
- Relevant industry experience such as pharmaceuticals, medical devices, biotechnology, or food and beverage is preferred.
What We Offer
- Competitive market salary
- The chance to personally impact a successful & rapidly growing startup, and have a direct impact on our customers.
- Work in small, highly motivated, cross-functional teams that pushes boundaries.
- Company events and after-work events
Interested?
Then apply for this position by clicking on the apply button. All applicants must send an updated CV in English