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Software Quality Engineer

Plymouth, Minnesota 55442

Category: Technology Job Number: 18100

Voca Technology has immediate openings available for Software Quality Engineer professionals in Plymouth, MN! Interested candidates will forward current resume to Chad Miller at cmiller@myvoca.com and call 952-303-8107. Thanks!

 

Position Details 

Job Description

  • Responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized throughout Client.
  • 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.
  • Ability to travel including internationally.


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