Production Quality Assurance & Control Specialist

SoniVie located in Rehovot industrial park are seeking for Quality Assurance & Control (QA/QC) professional to support production scale-up activities in a growing medical device company. The candidate will be responsible for ensuring compliance with regulatory requirements (ISO 13485, FDA QSR) and internal quality policies throughout manufacturing. This role involves close collaboration with production, engineering, and R&D teams to monitor product conformity, and support continuous production improvement initiatives.
Key Responsibilities
• Perform QA/QC processes to support continuous production control and scale-up activities.
• Conduct final product release and ensure complete and accurate documentation.
• Oversee maintenance and calibration of production tools and test equipment.
• Supporting QA activities such as: Supplier quality certificates overview.
• Handling of non-conformances, including supporting the R&D and Engineering during root cause investigations, and ensure timely resolutions.
• Oversee returned product processes, ensuring proper documentation, root cause investigations, and implementation of corrective actions.
• Maintenance of production quality records, including Device History Record files, in compliance with QMS requirements.
• Support in training and guidance to production staff on quality standards and procedures.
• Assist in preparation for regulatory inspections and audits.
דרישות התפקיד
• Bachelor’s degree in Bio-Medical Engineering, Life Sciences, or related field (or equivalent experience).
• 3–5 years of experience in Quality Assurance/Control in the medical device industry (preferably working with Class IIb and above sterile products).
• Demonstrated knowledge of ISO 13485, FDA QSR requirements.
• Familiarity with IEC 60601-1, IEC 60601-1-2, ISO 10555-1, ISO 11135 requirements is an advantage.
• Hands-on experience with sterile product final release, nonconformities handling and DHR maintenance.
• Strong problem-solving skills with the ability to thrive in a dynamic, fast-paced environment.
• Excellent communication and collaboration skills in a cross-functional environment.
• Detail-oriented, organized, and proactive.
• English Proficiency (Reading and Writing)