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, or Engineering (any) along with five (5) years of experience in the job offered or related occupation is required. Work location: Iselin, NJ and various unanticipated locations throughout the U.S.Send Resume to HR Dept., Shoolin, Inc., 120 Wood Avenue S, Suite 611, Iselin, NJ 08830.