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