Job Category: Medical Device
Job Location: Boston

Growing Medical Device company is seeking a Quality Engineer to support post market challenges. Looking for someone who has strong GD&T experience to focus on complaint handling and sustaining engineering change reviews.

Responsibilities:
·         Support the maintenance and continuous improvement of the ISO 13485 quality management system processes.
·         Prepare reports by collecting , analyzing and summarizing data regarding quality processes/product capabilities, problems and trends, and quality related design & development topics
·         Lead the Corrective Action/Preventive Action process.  Promote effective and timely resolution to quality problems with the focus on true root cause and verified corrective action.
·         Serve as a Lead or Co-lead in the Internal Audit Process.  Schedule and perform audit activities, to include pre-audit planning, audit execution and evaluation and post-audit follow-up and recommendations.
·         Participate in external audits with ISO Registrar, Authorized Representative and other government agencies.
·         Interface with ISO Registrar, Authorized Representative and government agencies, as necessary.
·         Review and recommend improvements to the implemented Quality Management System (Quality Manual, Standard Operating Procedures and Work Instructions).
·         Collect process metrics and lessons learned, review and evaluate processes and work products and recommend improvements as appropriate,

Location: Lewisville, TX

Pay: $30-34/hr.

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