Sima Khayatian

About Sima Khayatian

Executive summary: • Over 15 years of diversified and progressive management experience in Quality Compliance and Quality Management Systems (QMS), CAPAs, Risk Management and Product Development for Medical Devices, Complaints, quality engineering, supplier relations, materials planning/purchasing, production planning, training, customer satisfaction, and recruiting • Demonstrated success in gap analysis in a wide range of industries including Medical Device, FDA regulated industries, aerospace, and commercial • Key strengths include establishing vision and direction, resource and budget management, program management, lean implementation, scheduling, presentation, negotiation, training, and problem resolution • Successful track records in team building and interacting with different functional departments to ensure seamless execution of multi-million-dollar contracts (including leading Global and virtual teams)• Strong analytical and organizational skills, and ability to multi-task in a dynamic environment • Direct liaison with major Customers and Suppliers in Medical Device, and Aerospace companies• Certified Green Belt and Lead Auditor for 13485• Certified and assisted multiple companies with the Quality Compliance and QMS requirements including AS9100, ISO 13485, ISO 14971, and ISO 9001 – represented companies as Management Representative• Experience in developing quality remediation plans for inspectional observations (i.e, FDA Form 483) submitted by US Food and Drug Administration

Experience

1. Manager, Supplier Quality

   Advanced Sterilization Products

   Jun 2015 — Present · Orange County, CA, US

   Leading Supplier Quality Engineering team in managing External Manufacturers and Component suppliers, including leading Global and virtual teams• Direct interaction with Suppliers to establish Supplier Quality agreements• Represent supplier quality in on-going Management Review meetings• Member of CAPA, Issue Escalation teams - collaborate with the Cross functional teams, R&D, NPD, Sourcing, Supply Chain and other departments to ensure timely product qualification and delivery• Deliver quality system requirements through effective and timely investigation and closure of NCs, audit observations and CAPAs• Connect and partner with the internal business units for NPD in supplier selection and qualification• Subject Matter Expert for 3rd party and FDA audits with a thorough understanding of GMP regulations and experiences in regulatory inspection

Education

• University of Utah

  BS, Electrical Engineering

  1992

Skills

• Six Sigma
• Quality Auditing
• Gdp
• Quality Management
• Asq Training - Certificate of Biomedical Auditor Course (Cba)
• Iso
• Fda
• Lean Manufacturing
• Medical Devices
• Capa
• Electronics
• Iso 13485
• R
• Failure Analysis
• Quality System
• Root Cause Analysis
• Engineering
• Aerospace
• Iso 9001
• Spc
• Medical Device Directive
• Continuous Improvement
• Program Management
• Engineering Management
• Process Improvement
• Quality Assurance
• Medical Device Regulations
• Manufacturing
• Testing
• Cross-Functional Team Leadership
• Product Development
• Quality Control
• Gmp