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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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