Quality Engineer

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. Company Page: http://www.united-imaging.com/en/home/

Responsibilities

• Establishes Quality procedures and work instruction for Quality inspection and related areas. Trains personnel in these documentation and other technical process controls
• Ensures control plans and associated documentation are implemented effectively and maintained
• Drive Non-conformance processes; Quarantines, documents and evaluates products and materials; follow up with the action items and ensure they are closed out in a timely manner
• Manage Engineering Changes orders and engineering change process
• Support internal, external audit, management review, and quality data reporting
• Manage the calibration of tools and oversee equipment maintenance activities
• Plans, implements, and oversees the daily operations of EHS and Radiation Safety
• Oversees the review of radiation human-use clinical research protocols
• Provide training and/or other education as necessary to ensure the health and safety of employees and comply with safety regulations
• Manages the personnel dosimetry program
• Inspects organizational facilities (safety audits) to detect existing or potential incident and health hazards, determines corrective or preventative measures where indicated, and follow up to ensure measures have been implemented

• Bachelor degree or above in engineering or science;
• 2 years QE experience in medical device, automobile or other mechanical and electrical industries or experience in other field of quality management (preferred);
• Experience in project management (preferred)
• Be able to work in magnetic environment (e.g: no implantable metal in body)
• Familiar with ISO13485 (preferred)
• Familiar with FDA medical device regulation

Skills

• Excellent communication (written and oral) and ability to create and deliver presentations/ trainings.
• Excellent ability to multitask, attention to detail, and organizational skills
• Strong analytical skills
• Team player
• Work proactively;