Quality Assurance/Quality Control Manager

Cranston, RI 02910

Posted: 07/10/2019 Industry: Manufacturing Pay Rate: 110,000-115,000
  • Provide technical guidance to QC personnel.
  • Supervise personnel engage in final inspection and testing activities.
  • Act as the Management Representative Design within the Bio Detek 
  • Ensure a high level of external customer service.
  • Investigate customer issues and complaints relating to quality.
  • Investigate cause and quality problems identified  at incoming inspection, manufacturing and final QC inspection.
  • Create,document and implement inspection criteria an procedures.
  • Provide and oversee inspection activity  for product e throughout production cycle.Collect analyze and disseminated quality data throughout  the organization.Design develop and implement quality control training programs  in Material Review Board a
  • Adhere to and ensure compliance with quality systems SOP's work instruction drawings  Good Manufacturing Practices ISO and FDA requirements 
  • Provide support and participate in customer and agency quality audits.
  • Develop and implement quality improvement programs.
  • Lead department effort in CAPA investigation and completion 
  • Maintain the Calibration program
  • Participate in validation and verification planning activities,including protocol and report review.
  • Participate in Engineering Change Order review and approval activities as required 
  • Other duties as assigned 
  • Minimum 5-10 years related experience in a regulated environment, preferably medical device,5 years in managerial/supervisor role
  • Proficient at problem solving-analytical and diagnostics proficiency. 
  • Strong communication skills to include presentation capabilities.
  • Excellent verbal and written communication skills.
  • Experience with ISO 13485 and FDA QSR for medical devices and FDA Quality System. 

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Luisiana Martinez

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