We are looking for a QA/RA Specialist with a strong focus on the Software Development Lifecycle (SDLC) to join our team. This is a hands-on, onsite role, based at our offices in New York or Tel Aviv.
Youll be responsible for implementing and executing QA activities throughout the software development lifecycle (SDLC), while supporting the Quality Management System (QMS) in accordance with applicable regulatory standards (ISO 13485, ISO 14971, IEC 62304, etc.).
You will work closely with R&D, Product and Operations teams to ensure quality is embedded from design through post-release.
Responsibilities:
Participate in all phases of the software development lifecycle (SDLC) to ensure compliance with quality and regulatory standards.
Plan, document, and execute SDLC-related quality activities, including design controls, requirements, risk management, verification and validation cases, traceability and related release documentation.
Maintain and improve core QMS processes, including Design Controls, Document Control, Engineering Change Orders (ECO), CAPA, Non-conformances, Complaints, and Supplier management etc.
Collaborate with cross-functional teams to define quality gates and review development deliverables at each stage.
Support and/or lead internal and external audits, including ISO 13485, ISO 14971, IEC 62304 and CE/FDA inspections.
Provide ongoing QA/RA input from product concept through post-market activities.
Requirements: 2-3+ years of hands-on experience in QA/RA roles within a medical device or SaMD companies.
Fluent English (written and spoken).
Proven experience with SDLC. Familiarity with design control documentation such as ECOs, PRS/SRS, RMF, STD/STR, TRA, SVD, DHF etc.
Familiarity with ISO 13485, IEC 62304, ISO 14971, 21 CFR Part 820, CE, MDR etc.
Strong attention to detail and excellent documentation practices.
Ability to work independently, take initiative, and manage multiple QA/RA processes.
Strong interpersonal and communication skills, with the ability to collaborate across teams.
This position is open to all candidates.