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US-IN-Indiana: SENIOR QUALITY ASSURANCE ENGINEER
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
To apply for this position, please visit
this Website.
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com
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