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
– 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.
