Quality Assurance Specialist – CAPA and Complaints

Our Company

Gentuity is an exciting and highly innovative medical technology firm, active in the research and development, clinical translation, and commercialization of vascular imaging devices. This opportunity provides the candidates the unique chance to work on innovative medical products, with the potential to significantly change the practice of medicine in the care of patients suffering from a wide range of highly debilitating vascular diseases.

 

SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:

  • Control and oversee maintenance of documentation involved in the Quality system i.e., CAPA system records, Complaint system records, etc.
  • Lead CAPA – corrective action – initiatives in all areas of the quality and manufacturing
  • Perform product investigations on returned product and drive Complaint closure.
  • Provide periodic progress reports of the CAPA, complaint and continuous improvement activity.
  • Assist in reviewing, maintaining, and upgrading the document control system, i.e. – ETQ
  • Identify, investigate, and reports deficiencies and causes related to supplier problems and customer complaints.
  • Monitor the effectiveness of the improvement process.
  • Provides subject matter expertise, leadership, and training on investigational & Root Cause Analysis techniques, as appropriate, to other CAPA team members and to technical subject matter experts involved in the resolution of quality issues.
  • Evaluates and progresses the timely completion of CAPA system activities, including effectiveness checks, raised for non-conformances, potential non-conformances, CAPAs, deviations, and/or complaint investigations, as output from Quality System.
  • Ensure all CAPA and Complaint -related documentation is managed in a complete, clear, concise, and controlled manner.
  • Supports the attainment of goals and objectives; Accountable to the Quality Organization for achieving mutually agreed upon objectives.

 

Other duties as assigned

 

EXPERIENCE/SKILL REQUIREMENTS:

  • CAPA experience in a manufacturing facility.
  • Complaint handling experience desired.
  • 2+ years’ experience in a medical device environment.

 

EDUCATIONAL REQUIREMENTS:

  • Bachelor’s Degree, in a Technical or Scientific / Engineering discipline preferred, OR an equivalent combination of Education and Work Experience