Provides quality input and oversight to new product introduction, design transfer, supplier development, installations
and change control including specification and quality documentation development, review and approval.
Establishes controls of new components and assemblies through planning, evaluation and selection of suppliers, implementation
of acceptance activities, measurement, monitoring and feedback.
Work closely with purchasing, operations and engineering and supplier teams to ensure supplier readiness to deliver high
quality new products.
Implements process improvements for quality and efficiency related to incoming acceptance (FI \ CoC) process
Audits suppliers when appropriate
Continuously looks for opportunity to improve product quality and processes related to quality. Proactively create and
drive teams to drive improvements.
Work closely with Operations to implement and manage Process Validation procedure.
Own and manage Computer System Validation procedure.
Manage calibration activities for the Mountain View site.
Implement Electro Static Discharge procedure for ViewRay.
Audits and approves installation, supplier, manufacturing, quality, engineering, and verification documents for conformance
to business practices and departmental procedures.
NCR, SCAR and MRB activities
Works closely with operations and engineering to document CA and PA as appropriate
Reviews deviations from suppliers as well as internally generated
Support internal audits when necessary
Assist in definition of product development processes. Support Clinical Trials, prototype development.
Develop and write test and validation plans for components, subassemblies, and systems as appropriate. Document all plans,
inspection, test, validation activities to support incoming, in process and final acceptance of medical devices
B.S. in electrical/electronic, mechanical, biomedical, or industrial engineering discipline
5+ years of successful experience in a product manufacturing and supplier related product quality assurance positions
Experience of quality activities for new products related to supplier quality, manufacturing and installation
Knowledge and experience with FDA Quality System regulations including those related to Purchasing Controls, Production and Process
Controls and Design Controls
Ability to work independently as well as lead and work with teams supporting all Quality aspects in a Research and Development
and Production environment
Ability to launch new initiatives and follow through the completion
Process improvement capability and experience (for example 6 sigma, Lean tools)
Hands on experience and thorough knowledge of UL and IEC requirements for medical devices
Knowledge of ISO and CE Mark requirements preferable