Sunnyvale, CA 94089
* Supports and/or creates Quality Engineering documentation such as Quality Plan, Validation Master Plans and Reports.
* Participates in development projects by providing quality engineering services to assigned projects. Ensure defendable engineering and scientific analyses are employed and design history files comply with company policies and governmental regulations.
* Provides project with guidance on sound design control strategy compliant with Quality System Regulations (QSR) and Quality Management Systems (QMS), supporting a product release that is safe and effective, meets intended use, and is sustainable in the field.
* Understands and applies the manufacturing quality toolset including NCR, SCAR, SRB, MRB, PFMEA, IQ, OQ, PQ, GR&R/measurement system analysis, control plans, process verification/validation plans, validation protocol development, Cpk, Cp, SPC, hard gauging applications, computer-based inspection methods, operator work instructions, DOE, process data analysis, and DMAIC.
* Reviews drawings to evaluate quality requirements including correct application of geometric dimensioning and tolerancing (GD&T), proper use of engineering, process and material specifications, and identification of key characteristics for inspection plans and methods. Recommend revisions to assure design requirements are specified in the appropriate detail and clarity to provide a successful design transfer.
* Attends and guides product risk assessments, ensuring effective hazard identification, appropriate risk controls identification, and appropriate documentation of risk assessments
* Works with product support teams, engineering and others on component quality issues and supplier initiatives.
* Attends meetings and work effectively with extended teams which may include Manufacturing, Engineering, Research and Development, Quality, Regulatory and Marketing.