Description
BASIC SKILLS/EDUCATION/EXPERIENCE REQUIREMENTS:- B.S. in Engineering, Life Sciences or related medical/science field
- Minimum 7-10 years of relevant experience in the medical device industry
- Strong working knowledge of statistics
- Experience in FDA QSR/GMP, ISO 13485, and MDD
- Knowledge of design controls, ethylene oxide sterilization, environmental monitoring, biocompatibility, shelf life/accelerated aging, verification and validation
- Ability to make decisions related to product quality and release of the product
- Excellent interpersonal skills and ability to work well in a team environment
- Ability to provide and implement solutions to quality problems
PREFERRED SKILLS/EDUCATION/EXPERIENCE:
- M.S. in Engineering, Life Sciences or related medical/science field
- Biomedical Engineering and Mechanical Engineering are preferred Engineering disciplines
- Quality Engineering experience with US Class II, EU Class IIb or higher medical devices
- ASQ Certified Quality Engineer (CQE)
- Working knowledge of machine shop technology, electropolishing, ultrasonic welding, laser cutting, passivation, and clean room technology
- Working knowledge of ethylene oxide sterilization validation, environmental monitoring, biocompatibility, packaging and shelf life/accelerated aging requirements
- Working knowledge of ISO 9001, Geometric Dimensioning & Tolerancing (GD&T)
- Experience in an outsourced OEM environment; experience with contract or virtual manufacturing
To find out more about Real please visit www.realstaffing.com