Quality Auditor ISO 13485- Cleveland, OH (1099 Contractor)

Pro QC International North AmericaCleveland, OH
Onsite

About The Position

Since 1984, Pro QC International goes above and beyond the traditional roles of quality control. We assist clients to put better quality products on the market by resolving quality and production related challenges and reducing supply chain risk and cost. Pro QC offers solutions in over 88 countries. We manage our global operations from 18 Offices Worldwide. Our clients range from small start-ups to multinational companies in the Americas, Europe, Asia, the Middle East and Africa. Join Our Team We are always looking for talented candidates in Asia, Americas, Europe, Middle-East, and Africa. At Pro QC, we value quality over quantity. We value professionalism, dependability, and teamwork. We believe in building trusted partnerships that are earned through conscious efforts. In our strive for excellence, we are passionate about delivering quality solutions to organizations around the world. Leveraging an ever-expanding, interconnected group of people from diverse backgrounds, Pro QC offers an attractive and unique opportunity as part of a global family. Our Vision : To nurture the trust of our customers and our team through dynamic interactions, creative supply chain solutions, and integrated partnership.

Requirements

  • ISO 13485 certified or trained
  • Require a manufacturing and operations background and medical device expertise
  • 2–4+ years in quality management or medical device industry
  • Experience with QMS processes (CAPA, validation, design controls, etc.)

Responsibilities

  • Performing the audit at the manufacturing sites of our clients' suppliers per Pro QC checklists.
  • Using the process audit to identify relevant risks and point out potential issues.
  • Looking at audit findings and classifying them against the ISO 13485 requirements.
  • Communicate findings with the audit team and issue audit report within due day.
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