Senior QA/Verification Specialist

Alamar Biosciences•Fremont, CA

5d•$120,000 - $140,000

About The Position

At Alamar, we are passionate about enabling our customers to make scientific discoveries that translate into clinical outcomes and benefit patients. Our team is growing quickly as we develop innovative approaches to measure critical protein biomarkers from liquid samples that can enable the earliest possible detection of disease. We believe the next frontier in biology is enabled by measuring proteins at higher sensitivity in highly multiplexed assays at the push of a button, which is something only Alamar can do. As we build our team, we seek collaborative, driven, intellectually curious people committed to solving complex challenges. Our culture rewards accountability and cross functional teamwork because we believe this enables the kind of breakthrough thinking that will accelerate our mission. We are seeking a detail-oriented and experienced Senior QA/Verification Specialist to join our team. In this role, you will be responsible for ensuring the quality, reliability, and regulatory compliance of our software products. You will design and execute comprehensive test cases, and develop FDA-compliant documentation in support of our product submissions and quality management system.

Requirements

Bachelor's degree in Science or Engineering.
6+ years of experience in quality assurance, preferably in a regulated industry (medical device, pharmaceutical, or life sciences).
Demonstrated experience writing and executing test cases and test plans.
Hands-on experience maintaining FDA regulatory documentation (e.g., 510(k)).
Understanding of FDA guidance documents, such as: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Familiarity with risk management frameworks such as ISO 14971.
Proficiency with defect tracking and project management tools.
Strong written communication skills with meticulous attention to detail.

Responsibilities

Plan, design, and execute functional, integration, regression, and system-level software tests across multiple product releases.
Author and maintain detailed software test cases, test plans, and test reports in accordance with internal standards and regulatory requirements.
Review, and maintain FDA-required software documentation, including Software Requirements Specifications (SRS), Software Design Specifications (SDS), Hazard Analysis, Traceability Matrices, and Verification & Validation (V&V) protocols and reports.
Ensure documentation aligns with FDA guidance, including 21 CFR Part 11, 21 CFR Part 820, IEC 62304, and relevant ISO standards.
Collaborate with software developers, product managers, and regulatory affairs teams to define acceptance criteria and quality benchmarks.
Identify, document, and track software defects through resolution using issue tracking tools.
Participate in design reviews and risk analysis activities.
Support internal audits, external audits, and FDA inspections by ensuring documentation is accurate, complete, and audit-ready.
Contribute to continuous improvement of QA processes, tools, and documentation templates.