Quality Consultant, Lead Auditor ISO 13485:2016, Quality Manager, Quality Engineer, Over 40 years experience in Quality, including MDSAP, MDR, MDD, FDA, CAPA, 8D, RCA, 21CFR820, ISO 13485, ISO 9001, Customer Complaints, document remediation for Medical Devices, QMS, Research & Development, Validation, Manufacturing and Auditing processes. Remediation of Corrective Actions following previous Notified Body audits.3rd Party Audits, Auditee, Managed Back Room, Subject Matter Expert, Strong Quality Assurance professional.• Worked as a Quality Consultant / Engineer at several Medical Device companies accredited to ISO 13485 and 21CFR 820 for 15 years, recent experience with MDSAP. Documentation:• Writing and upgrading documentation to appropriate Medical Device standards including ISO 13485, ISO 9001, 21CFR Part 820 and Medical Device Single Audit Program (MDSAP) standards, including Quality Policy, Quality Management System (QMS) Manual, Codes of Practice, (CoP), Standard Operating Procedures (SOP), Departmental Procedures (DP), individual Work Instructions (WI) and Records and Forms.• I have produced a complete QMS which achieved accreditation to ISO 9001 from zero for a fledgling company.• Performing and documenting Corrective and Preventive Actions (CAPA) as Co-ordinator and owner, CAPA projects, 8Ds, Root Cause Analysis (RCA), Supplier Corrective Action Reports (SCAR).• Writing test Validation and Verification protocols IQ, OQ, PQ.• Reviewing and updating Customer Complaints.• Raising documentation for Technical Files submissions.Audits:Lead Auditor ISO 13485:2016Subject Matter Expert (SME) for an FDA Audit.Front Room Host for 3rd party Notified Body audits.Managed Back Room for successful MDSAP audit with zero nonconformities.Has a Certificate in Internal Auditing to ISO 13485:2016, ISO 9001:2015 and FDA 21CFR Part 820 – 2018.