Medical Device Software Quality Engineer

🔥 13 minutes ago

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Deciphex

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

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

• The Medical Device Software Quality Engineer reports to the Quality and Regulatory Affairs Manager. • Supporting software quality for medical device product development. • 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. • Lead and maintain end‑to‑end risk management for software and AI. • Support control of nonconforming products: document, track and follow up on nonconformances. • Support preparation and maintenance of Health Canada medical device licence applications and MDSAP documentation.

🎯 Requirements

• Degree or equivalent in a relevant discipline (e.g. life sciences, engineering, quality management, regulatory affairs) or equivalent experience. • Minimum 3 years of experience in a quality, regulatory, or related role in a medical device, IVD, pharmaceutical, or regulated software environment. • Good working knowledge with ISO 13485 QMS requirements or FDA 21 CFR Part 820; exposure to UK, EU, MDSAP or Health Canada medical device regulations is desirable. • Good working knowledge of software as a medical device (SaMD) or IVD software concepts including IEC 62304, is desirable. • Experience with document control, CAPA, complaint handling, or audit support processes in a regulated environment is an advantage. • Basic familiarity with US FDA medical device regulatory pathways (510(k), De Novo) and Health Canada medical device licence requirements; willingness to develop working knowledge of MDSAP and applicable US/Canadian regulations.

🏖️ Benefits

• Health insurance • Professional development • Flexible working arrangements