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Jobs or company...

Software Quality Engineer

  • Full Time, onsite
  • TekOne IT Services Pvt. Ltd.
  • Irving, United States of America
Salary undisclosed

Apply on

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Hello Everyone,

Greetings of the day.

This is Vydehi from Intellectt Inc. We currently have an opening for a Software Quality Engineer with one of our medical device clients. If you or anyone you know is interested in this opportunity, please feel free to send your updated resume to [email protected] or reach out to me directly at +1 732 355 7412.

Job Title: Software Quality Engineer

Location: Irving, TX

Duration: 12 Months

Description

This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized.

Duties
  • Develop and conduct training of company personnel for the divisional software development and validation program.
  • Work with Design and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes.
  • Create and execute or direct software validation protocols traceable to system/software requirements. Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems.
  • Assist in the completion and maintenance of risk analysis, focused on software related risks. Design and implement various product and process improvement methodologies (i.e, Six Sigma and Lean Manufacturing).
  • Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving issues. Software scoping and Part 11 audits.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Performs other related duties and responsibilities, on occasion, as assigned.

Qualifications
  • BS Degree in Engineering or Technical Field or equivalent experience.
  • 2-5 years Software Quality Engineering experience.
  • Detailed knowledge of FDA, GMP, IEEE 1012 and ISO 13485.
  • Advanced computer skills, including statistical/data analysis and report writing.
  • Advanced Information Technology and data mining skills.
  • Prior medical device experience preferred.
  • ASQ CSQE certification desired.
  • Experience working in a broader enterprise/cross-division business unit model preferred.
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