Our client, a leading medical device manufacturing company, is looking for a Quality/Validation Engineer. This is for an initial duration of 2 years and is located in Holdrege, NE.
THIS IS NOT AN I.T. position.
(Candidates must be able to work on W2 without VISA sponsorship)
Quality Engineer II - Onsite - 2 Years Contract
Job Description:
The Quality Engineer is responsible for supporting sustaining activities through the application of Quality Engineering skills for medical devices.
This person will understand, improve, and control operational processes to realize predictable product flow while satisfying established Client standards of quality.
Additional responsibilities include cross functional support for the Quality Engineering and Quality Systems group.
This position is responsible to build sound technical and organizational competence within area of responsibility. Ensure the systems comply with applicable government regulations and standards.
Comply with all Client quality policies, procedures, and practices through consistent application of sound quality engineering/assurance principles.
Experience & Education: \
Education
B.S. degree Required.
B.S. degree in Engineering (Industrial, Mechanic) Desired
Experience
3+ Years Quality experience including Validation and Quality Engineering responsibilities.
Knowledge, skills and abilities:
Demonstrate success with statistical and problem-solving methodologies.
Excellent knowledge of the principles for Quality Engineering and Quality management as related to validation process on medical devices.
Strong understanding of failure analysis, test methods and engineering tolerances.
Strong verbal, written and interpersonal skills.
Proficient with Minitab or other statistical software, MS Word, Excel, and MS project.
Six Sigma Certification Desired:
ASQ CQE
Working knowledge of 21CFR820, ISO 13485.