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

REQUIREMENTS:

• 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

RESPONSIBILITIES:

• 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