US-CA-Carlsbad: QA Analyst

To see other opportunities, please visit http://sqa.fyicenter.com
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 reports 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 reports 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 reporting 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 documents with minimal supervision.

For more information, please write to us.

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