Available Position for Advanced Process Quality Engineer within the Health Industry. Full Time, Monday- Friday 8:00am-5:00pm. Salary $66K
* Bachelor degree in Engineering, Engineering related discipline or equivalent experience.
* ASQ-CQE or CQA desired.
* 3-5 year minimum in Quality Assurance or related functional area such as Design Transfer/Manufacturing Transfer; preferably in medical device, or other regulated industry.
* Knowledge of inspection methods in the design and production of electro-mechanical and/or mechanical equipment.
* Possess attention to detail.
* Eagerness to assist internal and external customers.
* Manage projects in a timely manner.
* Ability to conduct and document technical investigation.
The following experiences/skill sets are highly desirable:
- ISO 13485 and ISO 14971
- Industrial statistical techniques
- Development and implementation of design and process controls
- Geometry Dimensioning & Tolerancing
- Experience with SPC
- Familiarity with FDA Guidance on Design Controls and CAPA Methodologies
- Familiarity with the Quality System Regulation 21 CFR Part 820, and CGMP
- Experience with Design for Manufacturing
- Manufacturing Experience
- Knowledge of Poke Yoke (Error-Proofing) techniques
- Human Error Prevention and/or Reduction techniques
- New Product development/R&D experience
- Experience on participation providing support or defending during third party audits such as TUV, FDA, others.