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http://sqa.fyicenter.com/jobs/99683608_QA_Analyst.html
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Date: 20-Mar-2008
QA Analyst
Position Summary: Review, evaluate, classify and investigate all
product complaints relative to the identity, quality, reliability,
safety and effectiveness of medical devices. Evaluates and makes
re****ts to Regulatory agencies that reasonable suggests a device may
have or could have caused or contributed to a death or serious
injury.
Essential Functions: (1) Review, classify issues for complaint
criteria. (2) Use and maintain database(s), provide analysis and
trending data all on complaints. (3) Files regulatory re****ts with
assistance or independently (MDR and Vigilance for limited product
line). (4) Trend or assist in trending defect/complaint data and take
action on emerging events. (5) Liaison with groups who perform
additional investigation and who prepare written record of
investigation. (6) Interact with Technical Service, Manufacturing,
R&D, and Quality Assurance to develop and implement corrective action
plans. (7) Provide basic technical expertise and assistance in
handling complaints to comply with current FDA and International
re****ting regulations. Requirements Education required/preferred:
Bachelor's degree in relevant field preferred. Experience: 3 to 5
years quality assurance or quality control experience in the
biomedical field. Individual with a suitable college degree and other
relevant experience may quality. Preferred skills/qualifications:
Basic knowledge of medical devices, their development and quality
control. Understanding of FDA regulations for Class II and III
critical care devices with regard to MDR and complaint handling.
Ability to work in a team oriented environment. Computer literate with
skills in Word, Excel, Access, PowerPoint and database trending
analysis. Ability to write business and technical do***ents with
minimal supervision.
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com
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