“Designing Quality into Medical Devices”
Malik Khan, MS, MBA is a Director of Quality at Stryker Endoscopy in San Jose, CA. In his current role, he is part of the Senior Leadership team for a $1+ Billion Business Unit of Stryker and responsible for both Quality Engineering in Pre-market (New product development) and Post Market Surveillance.
Malik’s 10+ years of medical device experience involves devices used both inside and outside the Operating Room environment. He has been involved with multiple Mergers & Acquisitions including a recent $750M+ acquisition of NOVADAQ technologies by Stryker in which he was amongst a core team of individuals that led the due diligence and subsequent integration activities. Malik’s experience has included several successful FDA and other regulatory body audits. Prior to joining the Medical device industry, Malik was working in the Renewable Energy and conservation field and is a published author (ACEEE) for Thermal Energy Storage.
In one of his previous roles at Stryker as an Assoc. RAQA Manager, Malik successfully lead the creation of one of the largest Post Market Surveillance teams at Stryker consisting of Regulatory and Quality professionals. Malik has been on Stryker’s Corporate hub & spoke teams as a Divisional Process Owner for: Complaint handling, Medical Device Reporting and Mergers & Acquisitions – driving processes, systems and procedures across Stryker Corporation.
Malik received a Bachelor’s and Master’s degree in Mechanical & Aerospace Engineering from Rutgers, The State University of NJ and an MBA from University of Michigan in Ann Arbor, MI. He currently resides in San Jose, CA.
SAVE THE DATE — ASQ ANNUAL QUALITY CONFERENCE ON OCTOBER 8, 2019 AT MARRIOTT FREMONT, CA
Happy New Year 2019!
Welcome to ASQ Silicon Valley! With over 1000 members, who are working across industries in Silicon Valley and making an impact, we welcome new members from emerging industries including Autonomous Vehicles, Cloud Computing, Internet Security, Artificial Intelligence or Machine Learning. We host monthly meetings, mini-conferences, industry focus groups, and special activities. Members from this section have contributed to the quality improvement in semiconductors, manufacturing, medical device, software development, and automotive industries. This sometimes has taken the form of providing with expertise in ISO 9001/13485/14001 like quality or environmental standards for automotive, medical devices, telecommunication, aerospace or other industries, or contributing in daily work at over 200 other companies like Abbott, Amazon, Apple, Cisco, Genentech, Genomic, Google, Intel, Tesla or Xilinx.
We are planning an annual quality conference in Silicon Valley and many other quality related activities. I encourage you to get involved & make the quality impact together.
ASQ Silicon Valley Education Program
Recertification and Education Program Chair – Michele Harms!
Education Program Description
The ASQ Silicon Valley (ASQ SV) Education Program, was initiated in 1997 to support the education and training needs of those interested in quality. The curriculum provides training in areas covering ASQ certification preparation, ISO Standards, Regulatory requirements, statistical topics and many related areas of quality. The Program is managed and administrated by the Education Committee under the direction of the Education Chair. It includes several methods of classes: classical face to face, web-based/online, and courses customized for specific organizations.