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QA QE ExpertBioAI Health • Manchester, New Hampshire, United States
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QA QE Expert

BioAI Health
  • US
    Manchester, New Hampshire, United States
  • US
    Manchester, New Hampshire, United States
Apply Now

About

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.
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  • Manchester, New Hampshire, United States

Languages

  • English
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