Software Quality Assurance Specialist

1 week ago


Carlsbad, United States Actalent Full time
Job Title:
Software Quality Assurance Specialist

Job Description:

Actalent is seeking a skilled Software Quality Assurance Specialist to join our team. As a key member of our engineering and sciences services, you will be responsible for ensuring the quality and performance of our software products.

Responsibilities:

Design, develop, and implement quality assurance standard operating procedures and processes for all software products to comply with regulatory bodies.
Review and approve test plans and test cases to ensure that software meets desired quality and performance standards.
Issue test record documents to perform software verification by software test engineers.
Develop requirement traceability metrics (from user requirements to functional requirements).
Review and approve software documentation for regulatory submission requirements.
Facilitate design input, design lock, and software release ceremonies.
Review and approve software-related risk documentation (Safety, Security, and Usability).
Establish metrics to measure the quality and performance of existing and new software products.
Monitor and analyze software performance, user feedback, and defects to identify areas for improvement.
Work with product teams to ensure that software meets business and user requirements.
Review verification reports at the end of each release.
Review Software Bill of Materials (SBOM) to ensure all Software of Unknown Provenance (SOUP) tools or packages are up to date.
Own software-related FDA 510(k) submission documents.
Participate in the design and review of software architecture.
Keep up to date with industry trends and best practices.

Requirements:

Medical Device or Diagnostics Background (DNA sequencing)
SW Quality
V&V
FDA Docs

About Actalent:

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market.

Diversity, Equity & Inclusion:

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. We maintain an inclusive environment through persistent self-reflection, building a culture of care, engagement, and recognition with clear outcomes, and ensuring growth opportunities for our people.

Equal Opportunity Employer:

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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