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Analyst
Manufacturing/Medical Device/Quality Assurance
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Location: Irvine, CA
Pay Rate: Contract: 53 to 55.00 $/hr
Salary: 110.24 to 114.40 K$/yr
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Position Type/ Job Duration: Contract 6 months +
Education Required: BS 
Years Experience Required: 4

Industry:
Mfg
Job Posted: 10/23/2017
Should I worry about this date?
Apply Deadline: 10/25/2017
Job #: 134309LMB
Job order status: Client is actively seeking candidates
Relocation available: Not Available


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Our client in Irvine, CA a large medical device company is looking for a temp to hire Complaints Specialists to start immediately! Any past experience in the dental or health field is desired, as in nursing or dental assistant experience!

Responsibilities

  • Maintain quality systems to facilitate continuous quality improvements. This position is responsible for the maintenance and monitoring of a variety of cGMP documentation including complaint files, Medical Device Reporting (MDR), complaint processing system, investigations and closure, corrective action and preventive actions (CAPA), product investigations, complaint reportability assessment, and maintenance of other related quality system records as required..
  • Compiling adverse event investigation information
  • Ensuring compliance with all Federal and International regulations as they apply to medical devices manufactured.
  • Maintain complete complaint files for all customer complaints, according to procedures and instructions
  • Review all received complaints for regulatory reporting requirements (MDR/AE) within timeframe
  • Maintain awareness of new products, government regulations and requirements

Requirements

  • Bachelor’s degree in science, engineering, or equivalent years of relevant experience.
  • Advanced understanding and interpretation of domestic and international complaint handling and reporting
  • Minimum of (2) years of experience within regulatory affairs or medical documentation and reporting; medical device experience preferred
  • Healthcare, Dental Assistant or past nursing experience a plus!

Benefits

  • Great company benefits, Medical, Dental, Wellness Center and more!
 
 
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Related Keywords mdr, regulatory, complaints, capa, event investigation, mdr/ae, dental, healthcare, nursing
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