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Learn More About Proton Therapy
Learn More About Proton Therapy
 

Careers

Quality Assurance / Quality Engineer

Provide quality assurance/quality engineering support for product design and development, manufacturing, installation and service activities for large, complex medical device equipment. Maintain and support the company’s Quality Management System (QMS).

Job Duties:

  • Design control
    • Design Project and Engineering Change Control Support
    • Document and Record Review (Device Master Record (DMR) and Device History File (DHF))
    • Risk Management
    • Validation & Verification Support
  • Manufacturing/installation/service
    • Management and disposition of non-conformities
    • Review and maintenance of DHR
    • Change control, interfacing between operation and design activities
  • Support of Quality Management System
    • Change Control/Management, CAPA
    • Internal Quality Auditing
    • Maintaining QMS procedures, templates, and records
  • Other duties:
    • Product Standards compliance
    • Regulatory assessment, gap analysis, planning, and implementation
    • Ability to work beyond Regulatory Affairs/Quality Assurance and support privacy/security, occupational safety, environment, medical device, and other regulatory compliance, as needed

Education/Experience:

  • Bachelors degree in engineering or other technical discipline, or equivalent
  • 3-5 years experience in medical device – quality engineering, quality assurance, quality systems support or operational management.
  • Must have ISO, FDA and CE Marking experience
  • QMS Establishment and Maintenance experience
  • Strong research skills with ability to learn through independent research of topics
  • Strong analytical skills
  • Ability to act as a change agent - driving organization improvements and planning and leading activities, while fostering a culture of quality and productivity
  • Comfortable with a dynamic and rapidly changing workload and organization