Sr. Quality Engineer
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POST DATE 9/14/2016
END DATE 11/23/2016
Eden Prairie, MN
The Quality Engineer works as an integral part of the TE Medical engineering team responsible for designing and manufacturing high quality medical products. The QE is the leading voice of quality in new product development as well as the driving force to define and resolve customer quality issues and other day to day production issues. Responsible to provide Quality Engineering support across New Product Integration and Sustaining business lines as detailed below:
RESPONSIBILITIES & QUALIFICATIONS:
* Establish process metrics to evaluate process performance, define control points, and work with engineering, and manufacturing to ensure that minimum expectations are met.
* Support process validation studies for special processes to improve TE-Medical's quality assurance methodology. Support development of Product Validation Plans, IQ/OQ/PQ protocols, and Test Measurement Validations.
* Resolve any special quality, test, and certification requirements in cooperation with engineering and assure overall agreement between TE-Medical and customer drawings and specifications.
* Draft and execute design of experiments (DOE) and capability studies.
* Work as a part of a core team with Development and Manufacturing Engineering as required in new product introduction. Contribute to all new product deliverables, including Design and Process FMEA, Control Plans, etc
* Create Quality Inspection Plans for components and assembly.
* Work to affect Cost of Quality improvement projects
* Work with Manufacturing Engineering in the day-to-day identification & resolution of production issues
* Drive to resolve product return and customer complaint issues
* Support the new product develop processes to assure product meets customer requirements.
* Provide leadership to and be a capable resource for the development of and execution of statistical process control (and appropriate related methods).
* Support and manage the verification system at TE-Medical for new and existing products. Support 1st Article inspection program, process capability studies, and inspection audits to verify quality levels for problem P/Ns.
* Develop standard quality inspection procedures and methods.
* Promote compliance to company procedures
Required Experience, Knowledge, Skills, Abilities or Education:
* Five or more years of experience in quality engineering
* BS degree in science, engineering, or manufacturing.
* Demonstrated expertise in quality concepts, practices and procedures.
* Strong interpersonal skills are required.
* Ability to plan, establish and coordinate test and inspection procedures, conduct process capability studies, prepare statistical quality control data and develop statistical designed experiments
* Knowledge of FDA 21 CFR Part 820 and ISO 9001 or 13485
* Ability to travel as necessary.