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Quality Assurance Engineer

Houston, TX

Who are we?

UIH is a leading global medical device developer and supplier with a diversified portfolio of advanced imaging equipment and healthcare IT solutions. We are building an innovative team with the mission of developing and supplying advanced technologies and improving patient care worldwide. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

This position will require international travel and training for 2 weeks in Shangahi, China.

 

Responsibilities

  • Lead to establish, maintain and monitor quality management system and ensure its effective operation;
  • Make project quality plan and implement it in the process to ensure project delivery quality;
  • Instruct project design transfer and production import to ensure smooth connection between R&D and production;
  • Monitor and instruct product change process to ensure that process is controllable and product quality is reliable;
  • Summarize process improvement measures from above activities and drive continuous process improvement;
  • Lead to post-market product quality monitoring and improvement, complaint handling and related post-market surveillance activities;
  • Organize internal, external audit, corrective and preventive action (CAPA), find improvement points in quality system;
  • Ensure full compliance with the corporate rules and regulations and perform associated and other duties as required.

 

Requirements

  • Bachelor degree or above in engineering or science;
  • 2 years QA experience in medical device, automobile or other mechanical and electrical industries or experience in other field of quality management;
  • Knowledge of medical imaging equipment or large electromechanical integration products;
  • Experience in product development (preferred), project management (preferred), or customer quality problem analysis and handling;
  • Familiar with ISO13485 (preferred), ISO9001 or TS16949 quality system (preferred);
  • Familiar with medical device regulations (preferred);
  • Familiar with Oracle PLM or other EDM system (preferred).

 

Skills

  • Good working attitude and work proactively;
  • Good communication skills and ability to work under pressure;
  • Good reading and writing skills.

To Bring Equal Healthcare for All

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