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Software Design Quality Assurance Engineer
- San Diego, California, United States
- San Diego, California, United States
Über
Compensation: $130,000 – $150,000/year + bonus
Location: San Diego, CA
Schedule: Monday to Friday (Hybrid)
Responsibilities as the Software Design Quality Assurance Engineer
Design Assurance: Lead software quality activities across the development lifecycle to ensure compliance with regulatory standards.
Regulatory Compliance: Ensure adherence to IEC 62304, FDA guidelines, and quality system requirements.
Design Controls: Support development and review of design documentation including requirements, validation, and verification.
Risk Management: Participate in software risk assessments and ensure alignment with applicable standards.
Cross-Functional Collaboration: Partner with engineering, regulatory, and product teams to support development initiatives.
Qualifications for the Software Design Quality Assurance Engineer
Education: Bachelor’s degree in Computer Science, Engineering, or a related field required.
Experience: 8+ years of experience in software quality engineering within a regulated environment.
Certification: Relevant quality certifications such as ASQ or CSQE preferred.
Industry Knowledge: Experience in medical device or biotechnology environments with knowledge of IEC 62304 required.
Technical Skills: Experience with software development lifecycle, cloud-based systems, and quality tools.
Skills & Attributes: Strong analytical, communication, and problem-solving skills in a fast-paced environment.
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Sprachkenntnisse
- English
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