Company description / JD introduction

• The position of Quality Auditor will support the leading industry customers around the world
• This role will participate in ensuring compliance with company/divisional policies and procedures and with FDA and ISO requirements by reviewing non-conformances and audit findings to coordinate corrective action
• This individual will contribute to the team's efforts to promote a culture of quality during the QMS integration of several Process Transfers

• The ideal candidate values culture as much as technical skill, works with minimum supervision and has appreciable latitude for implementing actions

   

  Responsibilities/ Tasks

• Supports and leads the development of the Regulatory Compliance Strategy for the IM/EM transfer
• Assists on assessments (internal or at supplier) to identify any opportunities to reduce compliance risk
• Responsible for integrating the Audit Program (procedures, training and ETQ system) for IM/EM sites
• Escalates/communicates any risks identified in the project execution, as well as quality and regulatory compliance-related risks or opportunities, to the appropriate management level

• Participates in the project meetings as Regulatory Compliance Representative

   

      Education/certification

• BA/BS degree in science, engineering, health-related discipline or any other technical discipline

   

  Key skills required

• Proficient with Microsoft Word, problem-solving methodologies and quality tools, including but not limited to root cause analysis, FMEA, 5 whys, and Ishikawa diagrams