QA QE Expert

Bio-AI Health Inc.; Manchester (NH); On-site; USD 90,000 - 160,000; Full time

Job summary

BioAI Health Inc. is seeking a QA/QE Expert to ensure quality and compliance as we develop AI-driven cancer diagnostics software and IVDs. You will establish and maintain the QMS, support regulatory submissions, and lead audits.

The role requires deep knowledge of ISO 13485, IEC 62304, and CAPA, with collaboration across engineers, scientists, clinicians, and partners. You will work in a startup environment, helping to shape processes, quality culture, and traceability for software and AI-based

Qualifications

• BS or MS in engineering, CS, bioinformatics, or related field.
• At least five years in healthcare with preference for IVDs.
• Minimum 3 years in software quality engineering in medical devices or IVDs.
• Deep knowledge of ISO 13485 and USA Quality System Regulations.
• Deep understanding of CAPA, complaint handling, change control and nonconformities.
• Hands-on experience with ISO 13485 and IEC 62304.
• Knowledge of risk analysis (ISO 14971) and agile development.
• Ability to translate between engineers, data scientists, clinicians and commercial teams.
• Excellent communication and collaboration, detail-oriented.

Responsibilities

• Quality assurance and compliance verification for BioAI products.
• Establishing and maintaining the QMS in accordance with relevant standards.
• Maintain and pursue applicable certifications.
• Tightly work with product teams to ensure compliant design, development, manufacturing, deployment, and maintenance.
• Ensure development processes comply with regulatory and quality standards.
• Execute internal and supplier audits; host external audits.
• Execute on design control deliverables and interpret quality requirements for software development.
• Support an agile SW and AI/ML quality culture; design and maintain traceability processes.

Skills

Quality Assurance

QA/QE

Regulatory Compliance

ISO 13485

IEC 62304

CAPA Process

Audit Experience

Software Quality

Risk Management

Traceability

Agile / SDLC

Cross-functional

Education

B.S. or M.S. in engineering / CS / bioinformatics / related field

Job description

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.

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

development of software

• Support an agile SW and AI/ML quality culture
• Design, implement and maintain a traceability processes

Minimum Qualifications

• 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
• 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-are 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 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.