Manage specification, qualification and validation requirements. Write and execute engineering change orders related to Corrective and Preventive Actions (CAPAs), changes in Critical to Quality (CTQs), release of aging reports, updates to design history files. Conduct Risk based verification for GxP (GMP, GCP, and GLP) systems and laboratory equipment. Create, and update Failure Mode and Effect Analysis (DFMEA) for new implants and instruments. Design, develop and oversee validation components and work on inspection plans and Inspection Feature Assessment. Skills required: Auto Cad, Matlab, Kaizen, Minitab, Tally, Catia, Python, Ansys and Gap Analysis. Bachelor’s degree in Science, Technology, Engineering, Mechanical Engineering, Industrial Engineering, Biotechnology Engineering or any related field with 5 years of experience in job offered or related occupation is required. Work location: Metuchen, NJ and various unanticipated locations throughout the U.SSend Resume to HR Dept., Shoolin, Inc., 47 Bridge St, Building A, Metuchen, NJ, 08840.