A global medical device company located in Caesarea, specializing in the manufacturing of dental implants, is seeking a:
QA /RA Engineer (Design)
**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
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 requirement
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
- 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
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