Quality Assurance Engineer

A global medical device company located in Caesarea, specializing in the manufacturing of dental implants, is seeking a:

QA/RA Engineer (Design)

**Duration**: This is a temporary position for 9 months with a real possibility for continuation.

Note: The company welcomes applications from recent graduates with a relevant bachelor's degree, even without prior industry experience.

Job Responsibilities:

- Lead quality control and quality assurance processes throughout the medical device product lifecycle

- Develop and execute comprehensive test plans to ensure compliance with regulatory and functional product requirements

- Plan and perform validations and development tests for products and processes, including writing/reviewing protocols and reports

- Write, update, and approve development files, technical documents, and work procedures in accordance with regulatory requirements

- Collaborate closely with development and engineering departments to manage engineering changes in the product and manufacturing processes

- Prepare technical documents for submissions to regulatory authorities (EU MDR / FDA / ROW)

- Conduct employee training on quality and regulatory topics

- Monitor and track key quality metrics and lead continuous improvement initiatives

Requirements:

- Bachelor's degree in Life Sciences, Biomedical Engineering, Mechanical Engineering, Biotechnology, Chemistry, Materials Engineering, or similar field - mandatory

- Preferably about one year of experience in the medical device industry, with emphasis on QA and regulatory processes - advantage

- Knowledge of FDA CFR 820 requirements, ISO 13485 standards, and CE requirements for medical product development - advantage

- Experience in performing validations and quality tests for medical products - advantage

- Familiarity with risk management processes (ISO 14971) and medical product development processes

- High level of English proficiency (reading and writing technical and engineering documents)

- Ability to work with interfaces and excellent communication with various departments in the organization

- Excellent interpersonal skills and ability to work independently as well as part of a team