Job Responsibilities:
1. Support, uphold, and ensure the application of quality system procedures to facilitate the systematic and comprehensive functioning of various company departments, encompassing production, research and development (R&D), engineering, clinical operations, and regulatory affairs (RA).
2. Guarantee that the Company’s Quality System complies with ISO 13485, 21CFR820, and relevant regulatory guidelines and external standards.
3. Oversee the processes for Corrective and Preventive Actions, including devising, executing, and validating the efficacy of these actions.
4. Coordinate and oversee the handling or disposition of nonconforming products until the identified deficiency or unsatisfactory condition has been rectified.
5. Conduct audits of the Quality System and follow up to ensure ongoing adherence to company quality system procedures.
6. Provide training to company employees on the company’s Standard Operating Procedures (SOPs) and regulations and standards related to Quality Management.
7. Exercise control and monitoring over production processes and manufactured products.
8. Take the lead on Engineering Change Orders (ECOs) activities and review ECO documentation.
9. Examine Device Master Record (DMR) and Design History File (DHF) documents to confirm their completeness.
10. Review Device History Records (DHR) and give final approval for product release.
11. Collaborate with cross-functional teams to deliver high-quality solutions.

Educational and Experiential Requirements:
– Possess a Bachelor’s degree in a scientific field or Biomedical Engineering.
– Demonstrate effective leadership with at least 5 years of experience in a quality assurance role within a medical device company.
– Exhibit a keen eye for detail and the ability to create and review technical documentation.
– Display proficiency in interacting with various disciplines and clear and effective verbal and written communication.
– Capable of multitasking and functioning within a fast-paced and dynamic team environment.
– Proficient in both Hebrew and English, with strong written and verbal communication skills.