Senior Quality Engineer

Borns Medical stands at the forefront of medical breakthroughs, crafting miracles that usher new life through profound technological innovation. With a commitment to pushing the boundaries of possibility, Borns Medical exemplifies a harmonious blend of medical expertise and cutting-edge technology, redefining the landscape of healthcare miracles.

Core Job Responsibilities: 
• Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes. 
• Utilizes multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO). 
• Addresses and corrects product and process complaints. 
• Reports on contract manufacturer performance metrics and ensures management reviews. 
• Oversees audits of all quality system categories to assess compliance to process excellence standards. 
• Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management. 
Qualifications
• Degree Qualified with science or Engineering Degree with 3-5 years relevant experience in Medical Devices/ Pharmaceutical Industry. 
• Excellent working knowledge of process excellence / QE tools such as pFMEA , SE , statistical analysis , SPC. 
• Excellent IT skill eg , experience in minitab , excel reports. 
• CAPA and RCI experience. 
• Risk management experience.