Quality Assurance Engineer

Company Description

Premia Spine is revolutionizing the treatment of debilitating leg and back pain with the innovative TOPS™ System, the first-of-its-kind facet joint replacement solution. TOPS™ is the only novel non-fusion, motion preservation solution for the treatment of patients with major lumbar diseases—degenerative spondylolisthesis and spinal stenosis. Premia Spine is dedicated to developing advanced medical technologies. The TOPS™ System is designed to improve quality of life for patients, making a significant impact in the field of spinal healthcare.

Role Description

This is a full-time on-site role for a Quality Assurance Engineer located in the Netanya, Israel. The Quality Assurance (QA) Engineer is responsible for ensuring the ongoing compliance, quality, and reliability of Premia Spine’s medical devices through oversight of production processes, documentation control, and adherence to regulatory requirements (e.g., ISO 13485, FDA 21 CFR Part 820, MDR). The role encompasses process oversight and validation, measurement system control, maintenance of an effective Quality Management System (QMS) using computerized tools, and implementation of continuous improvement initiatives to maintain the highest product quality standards.

Job Requirements:

• Degree in engineering or science-related fields.
• Minimum 5 years of experience in Quality Assurance within a high-risk or implantable medical device manufacturing environment.
• In-depth understanding of ISO 13485, FDA 21 CFR Part 820 and EU MDR quality system requirements.
• Hands-on experience managing key quality system areas, including process validation, risk management, CAPA, change control, and document control.
• Proficient in measurement system analysis techniques and statistical analysis tools.
• Experience with computerized systems, including eQMS platform and electronic document control/e-signature systems compliant with 21 CFR Part 11.
• Excellent communication with multidisciplinary teams, documentation, and analytical problem-solving skills.
• Proficient in Microsoft Office applications and experienced with ERP and electronic systems.
• Proficiency in both spoken and written English.

Job Description & Responsibilities:

• Oversee manufacturing operations and associated processes, including process audits, non-conforming material management, and CAPA activities, to ensure compliance with quality standards and procedures. 
• Review, assess and approve production and quality documentation, including manufacturing records, test data, and related reports, manufacturing records.
• Support and evaluate quality control and measurement system activities.
• Track and trend quality data to identify system issues and recommend process improvements.
• Participate in process validation activities, including developing test protocols, executing the tests and preparing reports.
• Manage document control and quality system activities through computerized platforms.
• Develop, review and maintain procedures, work instructions and related quality documentation to ensure compliance with current quality standards and practices. 
• Identify and drive quality and process improvement initiatives across production and QA systems.
• Provide quality training and support to production and engineering teams to promote a culture of compliance and continuous improvement.