Job Description

We are seeking an experienced Quality Engineer to manage creation of quality deliverables on a diagnostic instrument design project which includes software development and IEC 62304 compliance . This role ensures the integration of quality into both hardware and software design processes, maintaining compliance with regulatory standards such as ISO 13485 , FDA 21 CFR Part 820 , and IEC 62304 . The successful candidate will work cross-functionally to ensure the diagnostic system meets all applicable safety, performance, and regulatory requirements.

Key Responsibilities:

• Lead and coordinate quality engineering deliverables for both hardware and software components of diagnostic instrument design projects.
• Ensure software development processes comply with IEC 62304 , including software risk classification, software requirements traceability, verification, and validation planning.
• Collaborate closely with Software Engineering, Systems Engineering, and Regulatory Affairs teams to ensure design controls for software are fully implemented.
• Support the development, review, and approval of Software Development Plans , Software Requirements Specifications (SRS) , Software Architecture , V&V Protocols , and associated quality documentation.
• Facilitate and participate in comprehensive risk management activities, including software-specific risk analysis in accordance with ISO 14971 and IEC 62304 .
• Maintain traceability matrices ensuring linkage between software requirements, design inputs/outputs, risk controls, and V&V activities.
• Ensure that software risk mitigations are properly documented, tested, and verified.
• Review and approve software test plans , protocols, and reports, ensuring alignment with user needs, intended use, and regulatory standards .
• Provide quality oversight of software change control processes during development and post-market phases.
• Participate in and lead design reviews , ensuring both hardware and software quality risks are addressed and resolved.
• Ensure compliance with IEC 60601 (electrical safety) and IEC 62366 (usability) standards, as applicable.
• Prepare and support documentation for regulatory submissions (e.g., FDA 510(k), CE Mark Technical File) and external audits.

Qualifications:

• Bachelor’s degree in Engineering (Software, Systems, Biomedical, Electrical, or related field).
• 10+ years of experience in quality engineering for medical devices or diagnostic instruments ,
• Strong working knowledge of IEC 62304 and ISO 14971 required.
• Familiarity with software risk management , software architecture documentation, and verification strategies.
• Experience with software/hardware integration projects in the medical device or diagnostics field preferred.
• Knowledge of additional standards such as IEC 60601 , IEC 62366 , and cybersecurity guidance (FDA, IMDRF) is a plus.
• Demonstrated ability to lead software-related risk management and quality planning activities.
• Excellent organizational, communication, and leadership skills.

Preferred:

• Experience with in vitro diagnostic (IVD) systems.
• Experience supporting regulatory submissions involving software-based medical devices .

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