US-IN-Indiana: SENIOR QUALITY ASSURANCE ENGINEER
To apply for this position, please visit this Website.
http://sqa.fyicenter.com/jobs/99679001_SENIOR_QUALITY_ASSURANCE_ENGINEER_.html
To see other opportunities, please visit http://sqa.fyicenter.com
Date: 05-Mar-2009



SENIOR QUALITY ASSURANCE ENGINEER

JOB DESCRIPTION Ensure products and assemblies meet specifications and
all applicable product quality, design and manufacturing process
requirements. Provide leadership in areas of product quality assurance
and quality engineering to drive business objectives, continuous
process and product improvements. Develop and maintain procedures to
ensure that statistical control is maintained in the critical
processes.

MAJOR RESPONSIBILITIES • Work closely with Manufacturing,
Manufacturing Engineering, Development and Technical Support to ensure
high quality products and processes are developed and deployed. The
activities include product design verification, process validation,
risk assessment, and FMEA. • Drive systematic approach in problem
solving and process improvement using quality engineering tools
include, but are not limited to, Six Sigma, DMAIC, Statistic Process
Control, Design of Experiment. • Conduct complaint investigations and
work with appropriate parties in providing corrective and preventive
actions based on sound engineering analysis. • Monitor and report on
First-Pass Yield (FPY), Defect Per Unit (DPU), Customer Feedback (CF)
and other necessary Quality metrics to ensure high product quality and
process improvement opportunities are identified. • Develop systems to
identify, analyze, correct and prevent issues that adversely affect
product safety and performance. Provide Manufacturing systems
expertise, knowledge, and leadership in support of production and
testing

REQUIRED QUALIFICATIONS • BS degree in engineering from accredited
college or university. • 3-5 years experience in a regulated (FDA,
ISO, & GMP) and fast paced manufacturing area. • Strong analytical
skill • Effective leadership and interpersonal skills • Good written
and verbal communication skills • Hands-on experience in statistical
analysis

PREFERRED QUALIFICATIONS • Certified Quality Engineer or Reliability
Engineer • Certified Six Sigma Black Belt • Experience in biomedical
research instrument or medical device manufacturing • Knowledge of ISO
13485



Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com

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