Quality Engineer

Requirements:
• Bachelor’s degree in Engineering or Computer Science
• 3-5 years’ experience in a highly regulated industry such as FDA, defense or aerospace (medical device preferred), with a thorough understanding of the regulations, standards, SDLC and quality management systems
• Must have experience on a product development team releasing software product to market for a highly regulated industry
• Thorough understanding of regulations, standards, guidance documents and best practices for software development in a highly regulated industry
• Detailed knowledge of software development, quality assurance and verification and validation testing
• Thorough understanding to manage software issue/ complaint investigations and CAPA procedures
• English language, both written and spoken, at near mother-language level
Position: