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9 Varex Imaging Jobs
Design Quality Engineer
Varex Imaging
posted 28d ago
Job Role Insights
Key skills for the job
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
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