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Medical Device Quality Management System Engineer Full-time Job

1 month ago Computing and ICT Cambridge   79 views
Job Details

Experience level: Mid-senior

Experience required: 5 Years

Education level: Bachelor’s degree

Job function: Quality Assurance

Industry: Medical Devices

Total position: 1

Relocation assistance: No

Visa: Only US citizens and Greencard holders

OVERVIEW:

We are collaborating with world-class hospitals in the Boston area to turn cutting-edge medical research into usable, meaningful products. We are developing biomedical optical imaging and medical robotics technologies and seeking a Quality Management System Engineer to join our talented team in Cambridge, MA. With several version 1.0 projects heading for FDA submission, this is an exciting time to be part of our growth and success! Be a part of the Quality team at our Healthcare Optics Research Laboratory and drive Quality for the development of unique electromechanical and software-based biomedical devices in collaboration with world-leading medical institutions. We are seeking a Medical Device Quality Management System Engineer (Engineer, Quality Assurance) who can support our Quality Management System and drive compliance.

RESPONSIBILITIES:

  • Support establishment, maintenance and continuous improvement of our Quality Management System
  • Lead execution of the Complaint Handling process
  • Lead execution of the CAPA process
  • Lead supplier quality management process
  • Support external and internal audit processes
  • Support eQMS tools

QUALIFICATIONS:

  • Engineers are developing professionals, acquiring the skills and experience necessary to become fully proficient in the field of product or process development
  • Requires a bachelor's degree in an engineering discipline plus 3 - 5 years of related experience, or a Master's degree in the field
  • Requires analytical and problem-solving skills
  • Interest in Quality Management Systems and ability to acquire a working knowledge of the requirements of FDA QSRs and ISO 13485
  • Experience with CAPA, internal audits and supplier management is a plus
  • Proficient in Microsoft Office
  • Must be a team player and possess strong oral and written communication skills

The company will not pursue or support visa sponsorship for this position.

Company Description
At Trendy Jobbers Limited we help organisations find staff. Our tradition of being able to streamline high-quality individuals each time precedes us.