Seeking a challenging QA/RA Full Time Permanent or Contract/Consulting position. Please contact by email sajazhar@gmail.comA Senior Quality Assurance, Regulatory Affairs, Quality Engineering, Manufacturing, Clinical Programs, Compliance Activities, Management Professional with more than 10 years of experience and a successful record in the Medical Device, Diagnostic, Pharmaceutical & Cosmeceutical industries in various capacities. Specialties: Quality Systems, Regulatory Affairs• Quality Systems: ISO 13485, FDA QSR• Assist in Regulatory Submissions: 510(k)• Technical Files, DHF Project Assessment, Management and Documentation• Quality System Development• Complaints, CAPA, NCR, Product Recall• Domestic and International Consulting on QSR, ISO, MDD and CMDR• Internal and External Audits• Supplier Quality Qualification, Supplier Audits and performance of Supplier Audits• Risk Management• Responding to FDA 483 and Warning Letter• Create Quality System Documentation (Quality Manual, SOPs, and Procedures)