Principal Quality Engineer Job
Job Code - 80335
Position - Full Time - Regular
Job First Active on: Wednesday, January 18, 2012
Principal Quality Engineer
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.
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
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
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
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