Intro:
Admetec seeks a Quality Assurance Engineer to ensure product quality, regulatory compliance, and process improvement. Key responsibilities include managing CAPA, inspections, supplier certifications, and fostering a quality culture across the organization.
Position Overview:
- Oversee and analyze market feedback, ensuring timely resolutions and process improvements
- Conduct regular inspections on production lines, address deviations, and initiate investigations to improve product quality and prevent discrepancies.
- Lead and manage CAPA and non-conformance processes, including root cause analysis, implementation of corrective and preventive actions, and verification of effectiveness.
- Oversee supplier certification processes and manage SCAR, while leading and addressing non-conformities related to incoming inspections.
- Lead and control production failures through MRB processes, complaints handling, and CAPA activities.
- Document, implement, monitor, and maintain quality assurance activities to ensure compliance with ISO 13485, MDR, and FDA regulations.
- Provide daily QA support to all departments, fostering a quality culture.
Requirements:
- Sc. degree or higher in Industrial Engineering & Management / Mechanical Engineering / Quality Engineering / Relevant education – Mandatory.
- At least 2 years of experience in quality systems in the medical device industry – Mandatory.
- Experience with Microsoft Office and CRM platforms
- Excellent reading, writing, and communication skills in English and Hebrew.
- Strong reporting, teamwork, and time management abilities
- Quick learner with the ability to analyze problems, work independently, and manage multiple tasks effectively.
- Highly motivated and accountable.
Job Scope: Full-time
Location: Center