Software Quality Assurance Analyst (IRC282351)

Our client is a global medical technology organization focused on digital surgery and robotic-assisted systems. It provides an FDA-cleared surgical platform used internationally and is developing a next-generation robotic solution

Requirements

• At least 3 years of experience in a quality role within the medical device, aerospace/defense, automotive or similar regulated industry.
• Good understanding and practical application of medical device regulations or respective regulations in assosiated regulated industry (e.g. IEC 62304, ISO 14971 and EU MDR requirements for SaMD).
• Good understanding of Design Controls, Risk Management techniques (FMEA, FTA), Root Cause Analysis, CAPA processes, Auditing techniques (internal/external) practical application.
• Good understanding of SDLC models (Agile, Waterfall, Hybrid), Software V&V methodologies, Configuration Management principles, Change Control processes, Traceability tools/techniques.
• Good proven experience of reviewing and approving software lifecycle documentation and V&V artefacts.
• Good understanding of Computer System Validation (CSV) process and experiance in review of related deliverables.
• Good understanding of Quality Management System standards (ISO 9001, ISO13485, FDA 21 CFR Part 820 and related)
• Experience of conducting or participating in internal/external quality audits.
• Bachelor’s or Marter’s Degree in engineering field is highly desirable.
• Ability to understands and subsequently explain complex quality details to non-experts.
• Excellent written and verbal communication skills.
• Ability to work effectively cross-functionally and manage competing priorities.
• Exceptional organizational skills.

Job responsibilities

Leading review and approve of project documentation (such as development plans and reports, verification test plans and reports etc.), providing feedback and support team in order to ensure timely preparation and readiness of project deliverables;

Review and approve of CSV documentation;

Assessing project activities and deliverables against established procedures, standards and regulations as per established QMS;

Advising R&D team regarding implementation or adjustment of established processes;

Work closely with engineering, product, and support teams to ensure the quality and accuracy of project deliverables;

Communicating with a customer on quality assurance, process management, documentation preparation topics;

You will collaborate with R&D and product management teams to ensure robust quality processes and regulatory compliance;

This role is critical for ensuring patient safety, product effectiveness, and successful regulatory submissions.