Senior QA Engineer- Medical Devices (W2-Requirement)

Role: Senior QA Engineer- Medical Devices (W2-Requirement)

Location: Waltham, MA (Hybrid)

Duration: Long term

Job Description:

Project Overview

The customer is a global medical device company developing point-of-care diagnostic systems used in hospital and clinical environments.

Unlike traditional software testing roles, this position is strictly focused on process quality, regulatory compliance, and lifecycle oversight. You will act as the gatekeeper for software quality processes, ensuring the development team strictly adheres to medical device standards (e.g., IEC 62304, ISO 13485, FDA guidelines) and internal Quality Management System (QMS) procedures from concept through release.

Key Responsibilities:

Process Oversight & Compliance: Ensure all software development, testing, and release activities comply with ISO 13485, IEC 62304, and FDA 21 CFR Part 820/Part 11 requirements.

Design Controls & Traceability: Review and approve design history files (DHF), requirements traceability matrices, and software architecture documentation to ensure alignment with regulatory standards.

Validation & Verification (V&V) Review: Review and approve V&V plans, protocols, and final validation reports. (Note: You will be auditing and approving the validation processes, not executing the test scripts).

Risk Management: Participate in software hazard analysis and risk management activities (e.g., FMEA, ISO 14971 compliance) alongside the engineering and product teams.

Audit & QMS Management: Conduct internal process audits, drive CAPA (Corrective and Preventive Actions) investigations related to software, and ensure the project is continuously ready for external regulatory audits.

Experience Requirements:

Process Quality Experience: 7+ years in a Software Quality Assurance, Quality Engineering, or Compliance role specifically focused on process oversight (not just software testing).

Medical Device Expertise: Deep, working knowledge of medical device software regulations and standards (IEC 62304, ISO 13485, ISO 14971, FDA 21 CFR Part 11/820).

QMS Navigation: Proven experience working within a formal Quality Management System (QMS) and navigating Design Control processes for embedded systems or Software as a Medical Device (SaMD).

Documentation & Auditing: Strong analytical skills with the ability to review highly technical documentation for completeness, accuracy, and regulatory compliance.

Communication: Excellent cross-functional leadership skills to guide development and DevOps teams on quality best practices without slowing down the development lifecycle.