Osman Khan

About Osman Khan

Extensive experience in the medical device and aerospace industries.Extensive experience with CAPA and nonconformance systems; knowledge and understanding of FDA regulations (21 CFR part 820), ISO13485 and the application of QSR principles to the medical device industry.Broad experience in the implementation of Quality Systems, ranging from Medical Device Risk Management, CAPA and Nonconformance to Document and Configuration Control Systems.Quality Systems Regulations Certified Compliance Professional -2009.Subject Matter Expert (SME) for CAPA during internal and external audits (FDA and other notified body audits) at Boston Scientific, St. Jude Medical, Helix Medical and Bioness Inc. Remediated CAPA system at three major medical device companies (Boston Scientific, St. Jude Medical, Helix Medical)Implemented Risk Management Systems for medical devices at Helix Medical and Bioness Inc.Implemented Risk Management practices for Quality System elements at Bioness Inc.Implemented a new process to determine effectivity of QMS elements such as Internal Audit, CAPA and Management Review at Bioness Inc.Implemented Supplier Quality and Design and Development Process at Bioness Inc.Implemented ISO 13485:2016 and ISO 14971:2012 at Bioness Inc.Instrumental in transitioning QMS at Bioness Inc. to comply with ISO 13485:2016 and MDSAPISO 13485:2016 Lead Auditor Fabrication of space solar cells using photolithography and CVD at Ohio Aerospace Institute, Cleveland Ohio.Product Engineer for based multijunction space solar cells at a Spectrolab (Boeing Satellite Systems).

Experience

1. Director of Quality Assurance

   Bioventus

   Mar 2015 — Present · Cordova, TN, US

   Director, Quality Assurance, overseeing the following areas at Bioventus:• CAPA and Investigations/deviations• Nonconformance Reports• Supplier QualityExperienced lead auditor for MDSAP and EU-MDR regulations per ISO 13485:2016 and 21CFR820. Extensive experience with developing and maintaining effective quality management systems for Medical Devices. Developed novel methods of calculating the effectiveness of a QMS. Successfully completed a transition to the new EU-MDR regulations with zero observations. My expertise includes Management Review, Management of Suppliers, Configuration Control, Design and Development, Risk Management based on ISO 14971:2019 - in addition to elements such as CAPA and Internal Audit. I have extensive experience with CAPA systems and Root cause Analysis, which I consider my forte’.During my career, I have mentored and developed my direct reports into successful quality systems professionals.

Education

• Case Western Reserve University

  Bachelor of Science, EE

  1992 — 1997

Skills

• Manufacturing
• Powerpoint
• Microsoft Excel
• Photoshop
• Corrective and Preventive Action (Capa)
• Verification and Validation (V&V)
• 21 Cfr
• Root Cause Analysis
• Testing
• Design Control
• Fda
• Cross-Functional Team Leadership
• Iso 14971
• Regulatory Affairs
• Research
• Windows
• Iso 13485
• Medical Devices
• Capa
• Microsoft Office
• English
• Teaching
• Quality Assurance
• Quality Auditing
• Quality System
• V&V
• Outlook
• U.s. Food and Drug Administration (Fda)
• Validation
• Microsoft Word