Job Overview – Software Design Quality Assurance Engineer
Compensation: $130,000 – $150,000/year + bonus
Location: San Diego, CA
Schedule: Monday to Friday (Hybrid)
Atlantic Group is hiring a Software Design Quality Assurance Engineer in San Diego, CA for our client, supporting software quality, regulatory compliance, and design assurance within a medical device environment. This role focuses on ensuring compliance with standards such as IEC 62304 and FDA regulations across the software development lifecycle, including cloud-based and embedded systems. The position partners with cross-functional teams to support product development, risk management, and process improvement.
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.
Application Notice: Qualified candidates will be contacted within 2 business days of application. If an applicant does not meet the above criteria, Atlantic Group will keep your resume on file for future opportunities and may contact you for further discussion.