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.
Project Management experience.
