Junior Software Quality Support

3 weeks ago

Irving, United States PQE Group Full time

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.

Due to our constant growth, we are looking for a Software Quality Support Engineer to support our projects in Irving, TX. This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized throughout our client’s environment.

You will be responsible for:

  • 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.

About you:

  • BS Degree in Engineering or Technical Field or equivalent experience.
  • 1-3 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.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to travel

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.

If there's a positive match, a technical interview with the Hiring Manager will be arranged.

In the case of a positive feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal.

Alternatively, if the feedback is negative, we will contact you to halt the recruitment process.


Workin at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.

If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.

Apply now and take the first step towards an amazing future with us.

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