Promex Industries has named Hassan Sorkhabi Director of Quality / Regulatory Compliance. In this new position, Sorkhabi will be responsible for implementing an analytics-driven quality culture for the assembly of medical and biomedical devices and microelectronic products. He is currently updating the Quality Management System at Promex to ensure processes are robust and comply with medical device regulatory and quality requirements and with customer specifications.
“We deliver innovation by bringing quality into the initial product design and development,” Sorkhabi said. “For example, we use a pFMEA (Process Failure Mode Effect Analysis) to be proactive, rather than reactive. This reduces risk for our customers. In addition, by including validation (IQ, OQ and PQ) as part of our overall quality plan, we consistently achieve the highest level of quality in the production phase.”
An ASQ-Certified Biomedical Auditor, Sorkhabi has 25 years of engineering and management experience in the medical device industry. His expertise includes process quality engineering, FDA/ISO compliance, strategic processes and customer advocate/liaison functions. He has specific medical device quality management experience with glucose meters, lasers, monitors, Class III cool-sculpting instruments, non-invasive RF therapy systems and monitoring devices capable of detecting subtle changes in various physiological parameters. Sorkhabi has been involved in the launch of several of these medical products in the US, Europe, and Asia.
“To launch a medical device, OEMs need complete documentation and bullet-proof traceability, including Device Manufacturing Records (DMRs). They must comply with Federal (FDA 510K) and State quality requirements. If the product is being marketed in Europe, they’ll need a CE Mark as well. We fully support our customers in meeting all their requirements,” Sorkhabi said.
Prior to joining Promex, Sorkhabi was a Senior Medical Device Quality Consultant for Potrero Medical Inc. (San Francisco), the China/USA Senior Quality & NPI Manager for Harbor Electronics/Fastprint (Guangzhou, China), Director of Quality at Creation Technologies Medical Assembly Di-vision (Milpitas), Senior Medical Device Quality Consultant for Zeltique Medical Corp./OnCore Manufacturing (Fremont), Senior Operation, Quality and Regulatory Manager at Oracle Hardware (Menlo Park) and Director of Technical Program Management at Solectron (Milpitas). Sorkhabi holds a BS in Mechanical Engineering from California State University Sacramento and has taken several MS Industrial Management Certification Courses at San Jose State University.
For more information, visit www.promex-ind.com.