US: QA Engineer
To apply for this position, please visit this Website.
http://sqa.fyicenter.com/jobs/99659607_QA_Engineer.html
To see other opportunities, please visit http://sqa.fyicenter.com
Date: 04-Apr-2013

you will work on cross-functional teams to address product issues, define 
and implement effective corrective actions, and monitor post-implementation 
effectiveness. The ideal candidate will:* Be passionate about quality 
system processes and their continuous improvement in support of 
state-of-the-art implantable medical devices * Be energized by working for 
a world-class manufacturer and collaborating on cross-functional teams * 
Recognize the importance of building and maintaining strong interpersonal 
relationships Responsibilities include:* Making operational improvements * 
Performing product development and design control activities * Enhancing 
quality systems (including software implementation and validation) * 
Performing compliance audits * Selecting and approving suppliers * 
Training, teaching, coaching, and mentoring associates Other 
responsibilities may include:* Advising various teams (e.g., raw materials 
inspection, document control, maintenance and calibration, environmental 
monitoring and control, etc.) * Developing procedures and initiating change 
documentation in support of new and existing products * Developing quality 
reports to support assessments of quality-system effectiveness * Reviewing 
complaints

JOB REQUIREMENTS: Required Job Qualifications* At least 5 years' experience 
in a Quality Assurance role in the medical-device, pharmaceutical, biotech, 
or other regulated industries * Strong knowledge of/experience with quality 
system implementation and maintenance * Sound knowledge of FDA 
medical-device quality system regulations and ISO medical-device standards 
* Excellent written and oral communication skills * Strong interpersonal 
skills * Conflict resolution skills * Ability to: * Work independently, as 
well as part of a diverse team * Set and meet aggressive timelines


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

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