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 is fast – hours instead of weeks-, cheaper, and an entire panel of different genetic biomarkers can 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.

Come join BioAI and make a difference! We’re a fast‑growing team with industry experts and innovators in artificial intelligence, translational science and diagnostics. Our technology has repeatedly outperformed competitors in bakeoffs with pharmaceutical companies.

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 at BioAI.

Be prepared to thrive in an startup environment where culture and belonging are paramount and be a key part of developing it into an IVD company.

As the QA/QE Expert, you will be responsible for

• Quality assurance and compliance verification
• Establishing and maintaining the QMS in accordance with relevant standards and regulations
• Maintain and pursue applicable certifications
• Tightly work together with the product teams to ensure products are designed, developed, manufactured, deployed, and maintained in compliance to standards, regulations and QMS to ensure compliance of the development process with the regulatory and quality standards.
• Execute internal and supplier audits
• Host external audits
• Execute on deliverables from the Design Control process
• Support the development team to interpret quality requirements for the development of software
• Support an agile SW and AI/ML quality culture
• Design, implement and maintain a traceability processes

• B.S. or M.S. preferably in engineering, computer science, bioinformatics, molecular biology, or equivalent degree or
• At least five years of professional experience in 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 good understanding of IVDR or MDR
• Deep understanding of CAPA, complaint handling, Change Requests and Non conformities process
• Hands‑on experience with ISO 13485 and IEC 62304 includes architectural knowledge, ISO 14971 (Risk analysis) and working agile
• 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‑are 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 of 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.