Contract Lead Assessor|Trainer
BSI
Total years of experience :20 years, 5 Months
ï Providing management systems assessments services for Quality ManagementSystems including ISO 9001, Medical Device standards ISO 13485 and regulations CMDCAS, MDSAP, MDD and CE for North American Manufacturers (Canada/USA)
ï Providing public and private training to BSI clients QMS and Medical Standards and EU MDR (9001, ISO 13485, MDSAP and MDR)
ï Conducted Unannounced assessment under the EU MDD for class IIa, IIb and Class III medical device companies in Canada, USA
Trained internal and external Assessors on ISO 17021-2, IAF MD documents
Review of other Accreditation Body Reports
Providing technical information to potential and existing Canadian and international customer on Accreditation programs ( Management Systems and EnMS ) of Standard Council of Canada
•Performed ISO 9001 2008, ISO 13485: 2003 third party audits on diverse industries in North America.
•Planned and performed Stage I, Stage II, Surveillance and Re Certification Audits for conformance to ISO 9001: 2008 and ISO 13485 :2003
•Managed a pool of key customers and maintained a very high customer satisfaction rate.
Functioned as Subject Matter Expert for CAPA.
Reviewed and approved CAPA documents
Performed internal Quality Audits for ISO 13485 2003, FDA 21CFR820, EU MDD and Canadian MDR CMDCAS
Spearheaded the Exception Report Improvement Project and reduced CAPA wip by 17 %
Perfoming third party compliance ( Periodic and Certification ) audits for ISO 9001 2008
Reviewing quality documentation ( Quality Mnaual, Procedures and SOPs) for for complaince to ISO 9001 standard
Performed over 150 ISO 9001 compliance audits on diverse industries such as chemical & electronic manufacturing
•Reviewed advertising and promotional materials for regulatory compliance
•Assisted in submitting 510(K) clearance for Class II Medical device
•Achieved JPAL approval for exporting Medical Devices to Japan maintaining ISO 13485:2003
•Functioned as Management Representative
•Performed internal quality assurance audits to 21CFR 820, ISO 9001:2000, ISO 13485:2003, 93/42/EEC and JPAL regulatory compliance.
•Spearheaded the quality management system registration for ISO 13485:2003 and achieved ISO 13485: 2003 certification with one minor nonconformity
•Maintained the technical file & CE marking EU MDD compliance for Class II Medical device
•Established and improved QMS that improved finished good quality ratings by more than 50%
•Conducted supplier audits to ensure customer requirements were followed
•Spearheaded the quality management system registration for ISO 9001:2000 and achieved ISO 9001 2000 certification within 9 months and within specified budget
•Reduced field failure rate of finished good by 10 % over one year through continual improvement and by establishing comprehensive in process inspection and holding points
•Improved key customer ratings from 25 % to 85 % within one year by implementing and maintaining ISO 9001 2000 QMS
•Developed statistical analysis methods to maintain consistent product characteristics
Bsc - Industrial Management
Bsc - Industrial Management