Advanced Process Quality Engineer

Location: Arroyo, PR, Puerto Rico
Date Posted: 05-14-2018
Available Position for Advanced Process Quality Engineer within the Health Industry. Full Time, Monday- Friday 8:00am-5:00pm. Salary $66K

Job Requirements:
* 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.


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