Quality Assurance Engineer - Medical Devices

Posted 07 March 2023
Salary Competitive
Job type Full Time
DisciplineMedical Devices
Contact NameBenji Delaney

Job description

​Mantell Associates have partnered with a highly ambitious US Medical Device company, on their search for a Quality Assurance Engineer; This person will play a pivotal role within the QA team, helping the company develop the the next generation of Intravascular Imaging Catheters.

Quality Assurance Engineer 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 Organisation for achieving mutually agreed upon objectives

Quality Assurance Engineer Requirements:

  • CAPA experience in a manufacturing facility

  • Complaint handling experience desired

  • 2+ years' experience in a medical device environment

  • Bachelor’s Degree, in a Technical or Scientific / Engineering discipline preferred, OR an equivalent combination of education and work experience