Youll be responsible for implementing and executing QA activities throughout the software development lifecycle (SDLC), while supporting the Company compliance in accordance with applicable regulatory standards e.g ISO 13485, ISO 27001, SOC 2, ISO 14971, IEC 62304, HIPAA etc.).
You will work closely with R&D, Product and Operations teams to ensure quality is embedded from design through post-release.
Responsibilities:
Lead and oversee QA/RA activities across the full software development lifecycle (SDLC), including design controls, documentation, verification & validation, traceability, and regulatory compliance (ISO 13485, ISO 14971, IEC 62304, CE/FDA), while supporting release processes and audits.
Drive continuous improvement of core QMS processes (e.g ECO, CAPA, non-conformances, complaints, document control, management review, suppliers, training, human resources activities etc.), collaborate cross-functionally to enforce quality gates, and provide QA/RA guidance from product concept through post-market activities.
3-4+ years of hands-on experience in QA/RA roles within SaMD companies.
Proven experience with design controls (SDLC – ECOs, PRS/SRS, RMF, STD/STR, V&V, TRA, SVD, DHF etc.
Experience with ISO 13485, IEC 62304, ISO 14971, 21 CFR Part 820 etc.
Ability to work independently, take ownership, and manage multiple across.
Strong communication skills, with the ability to collaborate across teams.
Strong attention to detail and excellent documentation practices.
Fluent English (written and spoken).
