what in All Locations Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia Wyoming       Principal Quality Engineer Job Company - Medtronic Location -  Santa Rosa, California  US   Job Code - 80335 Position - Full Time - Regular Job First Active on: Wednesday, January 18, 2012 Principal Quality Engineer Position Description The Principal Quality Engineer (Extrusion) reports to the Sr. Quality Engineering Manager and leads technical Quality support and recommendations for process / system improvements concentrating on Medtronic product manufacturing and Quality department activities. The Principal Quality Engineer ensures the quality and conformance to specification of parts, components and finished devices. The Principal Quality Engineer also provides applicable regulatory compliance support for the implementation/maintenance of a GMP / ISO quality system. Position Responsibilities Leads quality engineering support to manufacturing operations, specifically plastics extrusion Assesses needs and opportunities, sets goals and drives execution Represents the Quality function in the manufacturing area. Leads by example to establish and maintain a Quality culture. Ensures compliance to internal and external requirements Drives continuous improvement in assigned work area. Uses continuous improvement tools to minimize variation, reduce lead time and reduce cost Implements and monitors manufacturing process controls, SPC, and manufacturing yield/scrap reporting Trouble shoots quality issues such as non-conforming material Provides technical support to other functions such as Regulatory Affairs for annual reports and 30-day notices. Develops and implements statistically sound sampling plans Owns implementation and validation of test equipment and methods used to support ongoing manufacturing. Evaluates repeatability and reproducibility of tests to ensure correct accept/reject decisions. Defines and executes process characterization and validation for implementation of process improvements and as required by procedures Communicates within Medtronic and with other Medtronic facilities regarding any quality-related problems. Ensures closure of the problem and remedial and corrective actions are implemented Assists in characterizing manufacturing processes for parts/components in development to ensure smooth transition from R&D to manufacturing Identifies and provides possible solutions for any issues that prevent the release of product to the field or to other Medtronic facilities Coaches and mentors other engineers Other duties as defined Basic Qualifications Bachelor's degree in Engineering (Mechanical, Plastics or Polymer) Minimum of 7 years experience in regulated industry (medical device/pharmaceuticals) with a Bachelor's degree or minimum of 5 years experience in regulated industry with a Master's degree Technical Knowledge of medical devices and Medical device industry Strong Quality engineering toolkit including advanced understanding and application of statistics, sampling plans, data analysis, DOE, GR&R, verification, validation, SPC, control plans, risk management, root cause analysis and tools (e.g. fishbone/Ishikawa diagrams), etc. Demonstrated application of lean manufacturing and six sigma tools and processes Understanding of Quality system architecture and requirements as they relate to regulated industry Experience with computer applications: MSWord, MSExcel, Agile, MSPowerPoint, MSProject, MSVisio Good prioritization and verbal/written skills including technical writing Ability to prioritize, manage, and accomplish multiple assignments simultaneously Ability to listen and understand multiple technical perspectives Ability to influence by understanding audience and articulating point of view supported with facts Judgment and decision making -- Ability to understand and evaluate risk Desired/Preferred Qualifications Master's degree in Plastics engineering Experience with extrusion of plastic components Experience with Class III medical device manufacturing ASQ certification in Quality Engineering Physical Job Requirements Lifting/Carrying 10 - 30 lbs. 0.5 hrs/day Bend/Stoop/Kneel 2 hrs/day Push/Pull 50 lbs. 0.5 hrs/day Stand/Sit/Walk 8+ hrs/day REQUIREMENTS - QUALIFICATIONS: Principal Quality Engineer See information above Apply to this job! View Company Jobs Free Career Test Your Resume on 75 Job Sites

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