Hassan Sorkhabi

• 8 D, CAPA, Pareto, Cause & Effect, 5Why, ü Start with a very early stage and work closely with Commodity management and supply chain group
• Audit new suppliers for sheet metal, solenoids, PCB and PCBAs, batteries packs, solenoids, displays, and cameras.
• Provide necessary documents, specifications, and built prototypes
• Manage Design History Files, Part submissions, Dimensional Analysis (Partial or full FAI), First Article
• Inspection samples
• PFMEA, Quality Control Plan, Measurement System Analysis, IQ, OQ, PQ, Verification report (DHR), Fixtures, Aids, Tooling, Deviations, and safe launch plan
• Work closely with compliance team and UL to receive UL certification for individual parts and system-level UL certification.
• Fluent with IPC 610 PCBA Assembly and IPC 600 Printed Circuit Board ü Work with third-party design houses, especially on End-of-Life components related redesign activities
• Travel for Guadalajara and Asia.

• Established SOPs for ISO 9001 & 13485-2016. Prepare thecompany for ISO ISO9001 & 13485-2016. Certify new company for ISO ISO9001 & 13485-2016 within 3 ½ months. Apply and receive California Department of Public Health - Food and Drug Branch ü Launch and validate new and non-medical Device customers.
• Skilled at working independently and collaboratively in a team environment

• I was responsible for PCB, PCBA, Wire-bonding, SOIC, and medical device semiconductor manufacturing.
• Selected and implemented Arena PLM systems.
• I was responsible for Quality Assurance, Quality Control, ISO 13485-2016, ISO 9001-201, and ISO14971 ü I wrote Protocol, Report templates, and related SOPs for Validation processes of IQ, OQ, PQ, pFMEA, and Quality Control document.
• Plan and VMP
• I managed all validation activities for new products and customer validation activities customers to meet Medical Device Validation requirements.
• Manufacturing Record (MDR)
• Resume ü I oversaw both Training and Document Control groups
• Launched customer’s new product, applied and registered company with both FDA and California FDB
• I conducted training for process engineers and other team members on quality, new SOPs, new QMS updates, and consequences that may occur from improper performance of their specific job
• I oversaw Internal, Customer complaints and Supplier Corrective and Preventive Action requirements
• I was responsible for Calibration, Maintenance, ESD, Internal and External audit, First Article Report
• Certification of Compliance, tracking, and traceability.

• Responsibilities included creating Medical Device quality strategies, FDA registration for OEM products, and managing end-to-end quality across operations.
• Partnered with key customers to establish a quality management system in alignment with customer quality best practices.a quality

• Operation, NPI, and Quality Supply Chain
• Responsibilities included creating quality/regulatory strategies for medical device products and providing regulatory expertise on daily issues.
• Managed contract manufacturing to validate medical devices, transfer and build
• FDA Class II high-volume production build
• Achieved ISO 13485 within nine months.

Operation and QA manager