Quality Assurance Engineer

Cranston, RI 02910

Posted: 07/10/2019 Industry: Manufacturing Job Number: 48877 Pay Rate: 90,000-110,000
  • Lead product quality investigations to a successful conclusion.
  • Execute risk assessments,collect supporting information and provide recommendations for management considerations.
  • Lead department effort in CAPA investigations and completion .
  • Interface with their departments to provide guidance an CAPA completion.
  • Provide technical guidance to QA and QC personnel. 
  • Represents quality interest and concerns on project  teams. 
  • Support manufacturing,new product and regulatory  to ensure systems and compliant with all internal and external requirements. 
  • Ivestigate cause of quality problems  identified at incoming inspection manufacturing and final QC inspection .
  • Collect, analyze,trend and communicate quality data throughout the organizations. 
  • Identify and help facilitate continuous improvement ,corrective and preventive actions.
  • Resource in engineering Change Order review process.
  • Mentoring education and training of QC personnel.
  • Assume additional responsibilities as necessary at the discretion of QA management. 
  • Develop programs and mythologies  for analyzing and presenting quality system data. 
  • Identify program opportunity  for improvement and drive procedures updates when required.
  • Oversee calibration program. 
  • Adhere to ensure compliance with quality system SOP's,work instructions,drawings good manufacturing practices (GMO),ISO,and FDA requirements. 
  • Four year degree, preferably in a technical discipline.
  • 3-5 years related experience in regulated environment, preferably medical device.
  • Proficiency with MS Office. 
  • Familiarity with use of mechanical and electrical test equipment.
  • Knowledge of commonly use concepts ,practices and procedures related to medical device manufacturing. 
  • Ability to analyze and aggregate data using statistics.
  • Experience preferred with ISO 13485, ISO 14971 and FDA QSR  for medical devices.

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Luisiana Martinez

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