We are a leading Dental Implant company operating in global markets,
committed to the highest standards of quality, innovation, and regulatory compliance.
We are looking for a motivated and detail-oriented Quality Engineer to join our Quality Department and support the implementation and maintenance of our Quality Management System in accordance with international medical device regulations.
Key Responsibilities:
- Support the implementation, maintenance, and continuous improvement of the Quality Management System (QMS).
- Maintain quality procedures, SOPs, and work instructions.
- Support compliance with ISO 13485, FDA, and MDR requirements.
- Participate in internal and external quality audits.
- Maintain quality documentation and records.
- Handle production non-conformities (NCRs).
- Support CAPA (Corrective and Preventive Actions) activities.
- Assist in handling customer complaints.
- Support supplier qualification and supplier evaluations.
- Participate in employee training on quality procedures.
- Perform quality measurements and prepare quality reports.
- Support design change activities (ECOs) from a Quality perspective.
- Work closely with the Regulatory Affairs function on ongoing quality
and regulatory activities.
- Support additional quality projects as required.
Additional Details:
* Full-time position.
* On-site (non-hybrid).
* Location: Northern Israel
Requirements: - Bachelor's degree in Quality Engineering.
- Minimum 2 - 3 years of experience in Quality Assurance within the medical device industry.
- Knowledge of ISO 13485.
- Experience with FMEA risk management according to ISO 14971.
- Familiarity with Design Transfer processes.
- Familiarity with FDA (21 CFR Part 820) and EU MDR requirements.
- High proficiency in Microsoft Office.
- Fluent English (written and spoken).
Desired Skills:
- Strong technical and analytical thinking.
- Ability to analyze data and draw conclusions.
- Excellent organizational skills and attention to detail.
- Ability to work independently as well as part of a team.
- Hands-on approach.
- Strong interpersonal and communication skills.
- System-oriented mindset.
This position is open to all candidates.
