Senior Software QA Engineer - Medical Devices & Compliance

Merit Medical; South Jordan (UT); Sur place; USD 110 000 - 150 000; Plein temps

Résumé du poste

Merit Medical seeks a Senior Software QA Engineer I to ensure software used in medical devices and manufacturing systems meets safety, reliability, and regulatory standards. The role is day-shift in South Jordan, Utah.

You will develop quality plans, lead risk analyses, and oversee supplier qualifications, with responsibilities spanning post-market surveillance and audits under IEC 62304 and FDA guidelines.

Qualifications

• Bachelor's degree in relevant engineering discipline or equivalent experience.
• Minimum eight years in software assurance or regulated software development.
• Strong knowledge of IEC 62304, ISO 14971, ISO 13485, and 21 CFR Part 820.
• FDA software validation and cybersecurity analysis guidance expertise.
• Ability to interpret software architecture, code structure, and test coverage.

Responsabilités

• Develop and maintain software quality plans aligned with design controls and regulatory requirements.
• Lead software risk analyses including FMEA, hazard analysis, and cybersecurity activities.
• Review and approve test protocols, traceability matrices, and compliance reports.
• Evaluate and qualify software suppliers through audits and risk-based assessments.
• Lead investigations of software-related issues and support field event analysis.

Connaissances

Software QA

Risk analysis

Regulatory compliance

Supplier qualification

Post-market surveillance

Formation

Bachelor's degree in relevant engineering discipline

Description du poste

Merit Medical seeks a Senior Software QA Engineer I to ensure software used in medical devices and manufacturing systems meets safety, reliability, and regulatory standards. The role is day-shift in South Jordan, Utah.

You will develop quality plans, lead risk analyses, and oversee supplier qualifications, with responsibilities spanning post-market surveillance and audits under IEC 62304 and FDA guidelines.