Validation Engineer

Illinois  ‐ Onsite
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Description

Summary
  • This person is responsible for providing Quality Assurance review, oversight, guidance and direction for the qualification of the Product Software contained within the device or standalone software.
  • Responsibilities include reviewing the Software Development Life Cycle activities from the planning phase, through design verification and validation and all of the in-between activities.
  • Responsible for compliance with applicable corporate policies and procedures as well as external regulations.
  • Provide quality support and assurance for software verification and validation activities.
  • Assist and/or guide software requirements generation and associated verification strategies
  • Expertise in design controls, product realization, and Risk Management.
SKILLS:

Qualifications
  • Looking for Quality Engineer well versed in the medical device industry, specifically in the area of Design Verification for medical devices.
  • Must have the background to understand the deliverables fully and provide interactive feedback in reviews and approvals of software development documentation.
  • Experience working with IEC 62304 is desired.
  • Experience supporting Design Verification and Validation activities is required.
  • Comfortable leading/actively contributing to risk based evaluations using tools such as FMEA, FTA and Risk Analysis.
  • Experience working with Third Party Manufacturers is a plus.
  • ASQ certified Software Quality Engineer is a plus.
  • 5 - 7 years' experience in a team oriented environment
Start date
n.a
From
Synectics
Published at
27.04.2016
Project ID:
1118872
Contract type
Freelance
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