Software Quality Assurance Engineer

April 16, 2024
Reference key: es12160
Deadline date:

Job Description

Software Quality Assurance Engineer: An innovative MedTech company is seeking a Software Quality Assurance Engineer to bolster their team. In this role, you’ll play a pivotal part in supporting the development, qualification, and commercialization of cutting-edge, highly reliable medical devices and their associated software. Your contributions will directly impact the creation of life-changing products that improve patient outcomes and quality of life. If you’re passionate about ensuring the highest standards of quality and reliability in medical technology, this opportunity is tailor-made for you



  • Bachelor’s Degree in Computer Science or similar

  • 3+ years experience in working in a software quality role in a regulated environment 

  • Experience with verification and validation (V&V) 

  • Expert knowledge of IEC 62304 (Software Development Life Cycle)

  • Good working knowledge of ISO13485 and ISO14971

  • IEC 62366 knowledge preferred (Usability)

  • Understanding of MDR and CFR requirements

  • Prior experience with Jira/Structure/templated export or equivalent software tooling

  • Strong communication skills


  • Lead Software Quality initiatives for both new product launches and ongoing product development teams

  • Collaborate closely with software development teams to streamline processes for efficient generation and upkeep of regulatory documentation

  • Craft comprehensive test plans and test cases aligned with product and component-level requirements

  • Possess a thorough understanding of Quality Management System (QMS) principles, particularly those related to Design Controls

  • Conduct detailed assessments of the impact of design changes on commercialized products

  • Apply Six Sigma, Statistical Analysis and Lean principles to investigate and resolve issues, continuously striving to enhance quality

  • Take the lead in developing and reviewing risk management files, encompassing the risk management plan, product hazard analysis, FMEA’s, Risk Management Matrix, and Benefit Risk Determination

  • Ensure effective integration of feedback from validation, field service, post-market surveillance, manufacturing indications, CAPAs, HRAs, etc.

  • Demonstrate familiarity with ISO 14971 and IEC 62304 standards for medical device risk management and software development, respectively

  • Provide support across all aspects of QMS related to Design Controls

  • Regularly report on the status of Quality and Reliability metrics during phase reviews, facilitating informed decision-making and continuous improvement efforts