• The Medical Device Software Quality Engineer reports to the Quality and Regulatory Affairs Manager, supporting software quality for medical device product development • Software Quality for product development • Software lifecycle & AI model governance: Software Testing oversight: Own QA oversight of testing activities by reviewing and approving strategies, plans, and reports for software and AI verification and validation, ensuring adequate coverage of safety‑critical and AI‑critical functions • Support validation activities for software and processes: assist in the preparation of IQ/OQ/PQ documentation, test protocols and validation reports for IVD software and regulated tools used in US and Canadian GxP environments • Provide QA oversight across the full software and AI model lifecycle (requirements, design, implementation, V&V, release, maintenance) • Risk management: Lead and maintain end‑to‑end risk management for software and AI (hazard identification, analysis, control, and ongoing review) • Assist with compilation and maintenance of the design history file (DHF) and technical documentation under manager oversight • Support control of nonconforming products: document, track and follow up on nonconformances • Support labelling and instructions for use (IFU) review: check compliance of product labelling and user information with FDA and Health Canada requirements • Quality Management System (ISO 13485 / MDSAP) Maintain and update QMS documents and records • Support preparation and execution of internal audits: compile audit evidence, coordinate schedules, record findings, and track closure of audit actions under the direction of the Manager • Coordinate and track QMS training: maintain training records and competency matrices; schedule and confirm delivery of QMS and role-specific training across the organisation

• Lead the end-to-end quality strategy for Infinia • Define the Infinia-wide quality engineering architecture • Lead the design and implementation of modular and scalable automation frameworks • Build comprehensive test plans that validate performance, workload behavior, concurrency, and cross-platform reliability • Partner with architects, developers, DevOps, and customer engineering to integrate quality into early-stage system and feature design

• Develop and execute comprehensive test plans, test cases, and test automation for fintech applications • Conduct functional, regression, integration, and user acceptance testing • Test automation (Kotlin/Cucumber, .NET/Specflow) • Design and develop automated tests for new functionality • Close collaboration within the product team: developers, peer QAs, analysts, product owners, designers, business stakeholders • Report testing status • Release management

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description 100% remote and full-time, with benefits. Material traceability is a key trend in manufacturing, and especially critical these days. It also presents some complex challenges, so our mission is to take the "difficult" and break it down into a simple and elegant experience for our customers. We need someone who is interested in helping companies that make products prepare for the future of manufacturing. Whether those products are: - Packaged food and beverages - Vitamins - Machine parts - Chemicals - Electronics - Cannabis - Pharmaceuticals - Clothing These companies need a modern tool to solve their traceability and business challenges. What You'll Do: - Ensure the quality and reliability of our platform by designing and executing comprehensive test strategies. - Validate new features and test integrations to other systems. - Identify issues before they reach customers. - Help maintain quality standards for the tools and cloud infrastructure used daily by our development, customer success, and sales teams. You will need solid skills with manual software testing, with experience testing web-based applications. Ideally, you are familiar with: - Accounting and finance - Manufacturing - Warehousing - Inventory control concepts Bonus skills include familiarity with Ruby on Rails and Javascript-based apps and automated testing tools. Some basic programming knowledge or background is also a plus. Qualifications - At least 2 years of professional QA or product testing experience with commercial B2B or enterprise-level applications. - At least 2 years working remotely. - Excellent verbal and written communication skills. - Self-driven, think like an owner and care about the quality of your work and the end result. - Constantly curious and enjoy learning new techniques or skills. - Take responsibility for ensuring solutions solve customer pain and are easy to use, catching issues that would impact usability or data integrity. - Appreciate variety and a culture attuned to creating a solid, accurate and high quality product and customer experience. - Collaborative and able to give and receive constructive feedback and work well in a remote team with different time zones. - Great sense of humor about yourself and your work. - Find AI interesting, but do NOT use or need to rely on AI tools to do your work. Requirements - You must live in the USA or Canada. - We will not respond to inquiries via our public website, LinkedIn, phone calls, etc. Benefits - Health care - Dental - Vision - 401k benefits - Stock options - 11 paid holidays - 2 weeks of PTO that increases for each year of service