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 PredictX 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. Responsibilities 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 and 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 traceability processes Minimum Qualifications B.S. or M.S. preferably in engineering, computer science, bioinformatics, molecular biology, or equivalent At least five years of professional experience in the healthcare 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, including 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‑art eQMS systems Preferred Qualifications 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 Equal Opportunity Statement 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. #J-18808-Ljbffr