Software Quality Engineer in Monroeville, PA at DISYS

Date Posted: 5/23/2018

Job Snapshot

Job Description

Software Quality Engineer (SQE) for Medical Devices 

Location: Pittsburgh with possible travel to Florida and Europe (IRE)


Job Purpose for the Software Quality Engineer:

To work with as the stand alone SQE and be the link with customer requirements to deliver on a speciality software required to support customer speciality test equipment needs. Interface with customer SQE and relay requirements to client.


Key Responsibilities of the Software Quality Engineer:

  • Lead client through quality systems and compliance requirements for software installed on equipment used in Class II Medical device environment
  • Full working knowledge 21 CFR Part 11, 21 CFR Part 820 and Regulatory requirements 
  • Fully competent in Software Development Life Cycle (SDLC) process
  • Experience in creation and execution of test procedures, test scripts and traceability matrix.
  • Fully competent in Risk analysis and application
  • Provide oversight of Technical Writer(s)
  • Interface with equipment designer, programmer, project manager and other relevant technical professionals in both R&D and Commercial environments.
  • Experienced as author and approver of MVP’s,
  • Experienced as author and approver IQ, OQ, PQ documentation
  • Offer expertise in software development and engineering
  • Test software to specifications and designs.
  • Review and learn complex system requirements.
  • Offer software process management and control and knowledge of coding portion of software development process.
  • Offer quality software for release to production by writing and implementing test scripts.
  • Quality oversight of test databases and ensure integrity and currency.
  • Record and document actual results as per expected results.
  • Manage well organized test results record and generate historical analysis.
  • Create quality system documentation based on customer/company requirements
  • Support configuration management tasks on projects.
  • Offer performance and capacity planning support of hardware and operating systems.

Key Requirements of the Software Quality Engineer: 

  • Non-Disclosure Agreement with client
  • Excellent communication skills
  • Able to work with minimal supervision
  • Deliver work product per on time / per project schedule
  • Minimum 7 years SQE experience in a regulated environment
  • Experience working with analytical test equipment as SQE
  • Flexibility to travel (domestic and international)
  • Knowledge  SAT/FAT/IQ/OQ/PQ
  • Experience with FDA regulated software requirements for Class II Medical device

Desirable skills for the Software Quality Engineer: 

  • Knowledge in C or C++
  • Experience with Analytical Lab Instrumentation
  • Access to working templates and job aids to expedite deliverables

Job Requirements

Digital Intelligence Systems, LLC. is an Equal Opportunity Employer, M/F/D/V. We do not discriminate against any employee or applicant because they inquired about, discussed, or disclosed compensation. Email recruitinghelp @ disys.com to contact us if you are an individual with a disability and require accommodation in the application process.Digital Intelligence Systems, LLC. is an Equal Opportunity Employer, M/F/D/V. We do not discriminate against any employee or applicant because they inquired about, discussed, or disclosed compensation. Email recruitinghelp @ disys.com to contact us if you are an individual with a disability and require accommodation in the application process.