QA QE Expert

Job Description

Interested in helping to support the development of cutting‑edge AI products to empower cancer diagnostics and save lives? If so, we’d love to talk to you!

BioAI is an early‑stage company that has developed the unique AI‑powered Predict

X platform that analyzes digital tumor tissue slides to predict genetic biomarkers. It uses the patterns that specific genetic mutations leave in the tissue architecture and morphology. Unlike standard molecular testing, this approach is fast—hours instead of weeks—cheaper, and allows an entire panel of different genetic biomarkers to be analyzed from a single piece of tumor tissue. Our current customers are pharmaceutical companies that need effective tests to identify cancer patients eligible for their precision therapies.

As we begin to develop our own product portfolio and support pharma companies with the development of customized IVDs, we are excited to bring on a QA/QE Expert to ensure quality and quality procedures  prepared to thrive in a startup environment where culture and belonging are paramount and be a key part of developing it into an IVD company.

• Quality assurance and compliance verification.
• Establishing and maintaining the QMS in accordance with relevant standards and regulations.
• Maintaining and pursuing applicable certifications.
• Working closely with product teams to ensure products are designed, developed, manufactured, deployed, and maintained in compliance with standards, regulations, and the QMS.
• Ensuring compliance of the development process with regulatory and quality standards.
• Executing internal and supplier audits and hosting external audits.
• Executing deliverables from the Design Control process.
• Supporting the development team to interpret quality requirements for software development.
• Supporting an agile software and AI/ML quality culture.
• Designing, implementing, and maintaining traceability processes.

• B.S. or M.S. in engineering, computer science, bioinformatics, molecular biology, or an equivalent degree.
• At least five years of professional experience in the health‑care industry, with a strong preference for In‑Vitro Diagnostics.
• Minimum 3 years of experience in software quality engineering in the medical device industry or in‑vitro diagnostics industry.
• Deep knowledge of ISO 13485 and Quality System Regulations (USA) and a good understanding of IVDR or MDR.
• Deep understanding of CAPA, complaint handling, change requests, and non‑conformity processes.
• Hands‑on experience with ISO 13485, IEC 62304, ISO 14971 (risk analysis) and working in an agile environment.
• Self‑motivated to prioritize and manage workload and meet critical project deadlines with limited supervision.
• Ability to translate between engineers, data scientists, oncologists, clinical lab partners, and commercial team members to balance user needs, team efforts, and business goals.
• Excellent communication and collaboration skills, detail‑oriented and receptive to feedback.
• Experience in working with state‑of‑the‑art eQMS systems.

• Familiarity with molecular testing and the clinical laboratory industry.
• Solid knowledge of AI & ML methodologies and trends.
• Technical experience to weigh tradeoffs and to have in‑depth discussions with data scientists and engineers about the nuances of AI models.
• Familiarity with diagnostic test risk assessment.
• Familiarity with software development standards and agile project methodologies.
• Experience in startups, small companies, or other fast‑paced, ever‑changing environments is a strong plus.
• Track record of executing and launching successful AI & ML based products.
• Track record in project management.

BioAI believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.