Job Description

Quality Engineer – Software Validation & Supplier Management

We are seeking a skilled Quality Engineer with expertise in non-product software validation, supplier management, and SaMD quality support. This role will play a key part in ensuring compliance with FDA, ISO, and international regulatory standards while supporting continuous improvement of our Quality Management System (QMS).

Responsibilities

• Develop and execute validation strategies for software tools and infrastructure using FDA’s Computer Software Assurance (CSA) approach.
• Draft, execute, and maintain validation protocols, risk assessments, and reports.
• Ensure validation documentation aligns with FDA and ISO 13485 expectations.
• Plan and perform supplier evaluations, audits, and risk assessments.
• Maintain supplier quality agreements and monitor ongoing compliance.
• Support supplier onboarding and continuous performance monitoring.
• Contribute to SaMD design control documentation, including risk management, requirements traceability, and verification/validation.
• Support preparation of documentation for FDA pre-market submissions.
• Drive continuous improvement initiatives aligned with ISO 13485, IEC 62304, and FDA QSR.
• Lead CAPA investigations, internal audits, and process improvements.
• Provide training and guidance to cross-functional teams on quality best practices.

Qualifications

• Bachelor’s or Master’s degree in Engineering, Computer Science, Life Sciences, or related field.
• Proven experience in quality assurance or quality engineering within the medical device or SaMD industry.
• Strong knowledge of FDA CSA guidance, ISO 13485, and 21 CFR Part 11/820 requirements.
• Experience with supplier qualification and management.
• Familiarity with SaMD design control (IEC 62304) and risk management (ISO 14971).
• Hands-on experience with eQMS platforms and software validation in cloud environments.
• Excellent documentation skills and high attention to detail.
• Strong communication and cross-functional collaboration abilities.

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