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
– 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
