Sunnyvale, CA 94089
* Applies technical experience, skill and performance to achieve strategic goals through new product delivery from a Quality perspective.
* Works cross-functionally and consults frequently with Manufacturing, Engineering, Research and Development, Quality, Regulatory and Marketing, in addition to other functional groups.
* Routinely communicates project goals, status, requirements, and deliverables to Quality Program Manager and/or supervisor.
* Document the phase gate process for new product development from a Quality perspective and ensure compliance to policies and procedures.
* Function as the Quality Engineering representative and continuously communicate with Core Team members and their extended teams to deliver robust, manufacturable products which meet the defined delivery timeline, design inputs and quality metrics to meet business unit goals.
* Create the Quality Plan, Validation Master Plans and Reports
* Collaborate with Core Team on Quality-related project activities including risk assessments, and facilitates resolution for Quality-related issues escalated to the Core Team
* Communication focal point for the project to Quality Management, including Quality Program Manager and/or supervisor
Knowledge and skills:
* A minimum of three (3) years of FDA regulated environment experience
* Proven track record with design control in medical device system and/or reagent product development.
* Experience in the application of production and process controls including process validation.
* Experience with and/or practical knowledge about quality system audits.