Sujith Peiris Email & Phone Number

8+ years of experience in the Quality Compliance capacity within highly regulated environments specifically in Medical Device industry. Strong working familiarity with CMDCAS, 21CFR820, ISO13485, ISO14971 and MDD/CE quality systems and regulatory requirements associated with the development, production and registration of products in the medical device industry.Specialties:• Certified Quality Auditor• ISO 13485 QMS• Medical device regulations (MDR,CMDR,FDA,QSR)• External (3rd party), Internal and supplier audits• Supplier management activities• Complaint /CAPA/NCR process• Analytical and problem solving• CE marking• Project management• Change control process• Safety and EMC regulations• Documentation control management• Trend Reporting• Microsoft Office application

Listed skills include Iso 13485, Quality System, Medical Devices, Quality Auditing, and 28 others.