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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