Software QA Specialist

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Deciphex

WebsiteLinkedInAll Job Openings

51 - 200 employees

🤖 Artificial Intelligence

⚕️ Healthcare Insurance

🧬 Biotechnology

Artificial Intelligence • Healthcare Insurance • Biotechnology

Deciphex is a leading company revolutionizing the field of pathology by digitally networking pathologists globally and leveraging artificial intelligence to enhance the efficiency and quality of pathology reporting. Pathology is crucial to both healthcare delivery and drug development, and Deciphex addresses the growing demand-supply gap in this field by using digital pathology for workload balancing and AI for accelerating processes. The company specializes in providing digital pathology platforms, like Diagnexia and Patholytix, that support both clinical and research pathology. Deciphex enables on-demand remote consultations with subspecialty pathologists, accelerating diagnostic turnaround times and enhancing patient care. Their platforms are trusted by leading CROs and pharmaceutical companies, making Deciphex a pivotal entity in digital pathology and AI-driven solutions.

📋 Description

• Own QA review and approval across the SDLC — change control, test case review and approval, and test management • Support audits, CAPAs, and documentation control • Act as a key point of contact for customer quality questions, audit support, and questionnaires • Review quality assurance clauses in customer SLAs alongside our legal team • Get involved in the design and development of new features — including AI-based functionality — to ensure they meet quality and regulatory requirements • Support the release of products into GxP environments for internal and external regulated customers • Provide QA review and approval across our GXP services offering, including consultant enablement and GLP scanning validation • Collaborate cross-functionally with our pre-clinical software development team and our AI/automation tooling team

🎯 Requirements

• A minimum of 3 years' software development experience within a regulated environment (5 years preferred) • Genuine, hands-on GXP experience, you understand what 'fit for purpose in a regulated environment' really means • A Bachelor's degree in Computer Science or a related field • Experience with GLP software validation and verification • Comfort working in an Agile software development environment • Strong communication, collaboration, and problem-solving skills • The ability to work autonomously, you take ownership tasks without needing to be asked • Nice to have: Knowledge of GLP regulations, CSV/CSA, FDA 21 CFR 58, 21 CFR 11, OECD Principles of GLP, or GAMP 5 (2nd edition) • Experience with cloud storage of GLP data • ISTQB or similar software testing certification

🏖️ Benefits

• Competitive salary • A highly collaborative, supportive, and multicultural team • Regular performance feedback and genuine career growth opportunities • Minimal travel — occasional trips for audits or team meetings, with no regular onsite requirement