Product Software Validation Lead

2 weeks ago
# of Positions
Work Location (City/State)
Parsippany, NJ

Who We Are


Every day, our solutions affect people throughout the world. From Fortune 100 companies to start-ups, GalaxE develops and implements strategic projects that are critical to the success of customers’ businesses and the lives of tens of millions of people.


For over twenty-five years, we have grown and evolved into a multi-national firm that employs over 2000 team members worldwide. But we’re not done evolving. It took collaboration and innovation to get here, and it takes collaboration and innovation to get where we (and our customers) want to be tomorrow.  


What does this mean for our employees? They have the security of an established company, with the benefits of working for a company where great minds, hard work, leadership and innovation are highly regarded and rewarded.


As Thomas Edison said, “There’s a way to do it better – find it”. We want our employees to find it.


We’re looking for creative people, with an entrepreneurial spirit, looking to work on awesome projects! Sound like you? Come work with us! Find out for yourself what it means to be part of the GalaxE team.


It’s not always easy, but important work never is. #WeAreGalaxE


Equal Opportunity Employer/Veterans/Disabled

What You Will Do

  • Develop and conduct training for the divisional software development and validation program.
  • Work with multiple teams towards 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 (ie Six Sigma and Lean Manufacturing).
  • Provide problem solving methodologies in identifying, prioritizing, communicating, and resolving issues.
  • Software scoping and Part 11 audits, etc.
  • Comply 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.

Skills and Experience You Will Need

Required Skills

  • Experience / knowledge of compliance
  • Experience with Class 2 medical device validation and processes
  • Advanced computer skills, including statistical/data analysis and report writing skills
  • Multitasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail


  • Experience with Class 3 medical device validation and processes
  • Detailed knowledge of FDA, GMP, IEEE 1012 and ISO 13485



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