Quality Systems Engineer & Six Sigma Process Improvement Manager

Want a Quality Engineer challenge where your goal will be to improve processes so that you can be promoted into a position where you can lead a Six Sigma educational initiative?   If so the Biological Pharmaceutical & Medical Device Quality change agent who successfully attains this will provide Quality leadership via coordinating, reviewing and approving all Quality related investigations utilizing the DMAIC methodology.  Overall, you will use your Six Sigma tool kit to implement a methodical approach to project management, process improvements and Root Cause Analysis (RCA).  NOTE: You will be doing this in an extremely profitable and fast paced company that has experienced double digit growth in revenues and income year after year.  Responsibilities will also include: 1.  Leading a dept that provides final QA approval on all deviation, OOS, and complaint investigations.2.  Leading cross functional teams to determine root causes ( using DMAIC to perform Root cause Analysis/RCA ) 3.  Provide as needed training on 6 Sigma methodology.4.  Monitor and analyze sources of quality data to determine if systemic issues exist that require additional investigation.5.  Project management of the large scale change control events concentrating on manufacturing processes and equipment, laboratory systems and equipment, and automation systems and equipment.6.  Generate and report monthly metrics7.  Recommend best practices to multi-functional teams and incorporates those practices into project implementation. Qualifications:  1) Must have a BS in Science, Engineering or a related field.  2) While 4+ years of relevant pharmaceutical, biological or medical device experience is preferred, IT IS MORE IMPORTANT THAT YOU CAN SHOW UNDERSTANDING AND EXPERIENCE WITH:- Implementation of Six Sigma & DMAIC methodologies in performing RCA's and investigations. - Success with “influencing without authority” with cross functional teams and across departments.  - Project Management3) Six Sigma certification4) Preferences include experience with RCA, CAPA, investigations and change control management.