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7 Varex Imaging Jobs

Design Quality Engineer

2-5 years

Pune

1 vacancy

Design Quality Engineer

Varex Imaging

posted 6hr ago

Job Description

  • Apply knowledge of risk management to ensure a risk-based approach for design and process activities
  • Review and approve engineering change orders
  • Support customer requests (internal and external)
  • Support new product introduction for Sources and Detectors
  • Maintain and update technical files and risk management files to comply with global regulations
  • Participate in addressing audit findings
  • Support internal audits and external audits by regulatory agencies, as required.
Your Profile:
  • Bachelors Degree in life sciences, preferably in Electronic or Mechanical engineering
  • Minimum of 3 years of work experience with a focus on design control, risk management, and verification and validation.
  • 2+ years of global experience in regulatory affairs or quality assurance medical device, aerospace, defense or similarly regulated industry
  • Background with Medical Devices (ISO 13485), Electrical Medical Devices (ISO 60601), Risk Management ISO 14971, or Pharmaceutical.
  • Expertise and understanding to analyse the meaning of regulations for the business.
  • Understanding of safety requirements in this industry context.
  • Understanding of Quality Assurance management and experience in reviewing engineer change orders.
  • Basic knowledge of ERP systems and Microsoft software.
  • Strong verbal and written communication skills; ability to present issues, plans and objectives. Excellent organizational, problem solving, and analytical skills
  • Fluent communication in English.
  • Ability to lead priorities and workflow versatility, flexibility, and a willingness to work within constantly evolving priorities
  • Ability to collaborate with global team members
Additionally valued qualities:
  • Experience with the application of Data Science and Advanced Statistical Techniques
  • Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1, MDD/MDR, and IEC 62304, FDA s General Principles of Software validation.

Employment Type: Full Time, Permanent

Read full job description

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What Varex Imaging employees are saying about work life

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International travel
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Varex Imaging Benefits

Free Transport
Child care
Gymnasium
Cafeteria
Work From Home
Free Food +6 more
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