QA QE Expert

About the role

As a QA/QE Expert at BioAI, you will play a crucial role in ensuring the quality and compliance of our AI-powered PredictX platform. You will be responsible for establishing and maintaining the Quality Management System (QMS), conducting internal and external audits, and supporting the development team with quality requirements.

Responsibilities

• Establish and maintain 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
• Design, implement and maintain a traceability processes

Requirements

• B.S. or M.S. preferably in engineering, computer science, bioinformatics, molecular biology, or equivalent degree
• 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
• Excellent communication and collaboration skills, detail-oriented and receptive to feedback
• Experience in working with state-of-the-art eQMS systems

Qualifications

• Familiarity with molecular testing and the clinical laboratory industry
• Solid knowledge of AI & ML methodologies and trends
• Technical experience to weigh tradeoffs and 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

Skills

• Strong analytical and problem-solving skills
• Excellent organizational and time management skills
• Ability to work independently and as part of a team
• Strong written and verbal communication skills
• Ability to handle multiple tasks and priorities simultaneously

Benefits

Join a dynamic and innovative team where your contributions will make a significant impact. We offer a competitive salary, comprehensive benefits package, and opportunities for growth and development within a supportive and inclusive workplace culture.

Pay

Competitive compensation package based on experience and qualifications.

Schedule

Full-time position with flexible working hours to accommodate the needs of a fast-paced startup environment.

Benefits

We offer a comprehensive benefits package including health insurance, retirement plans, and paid time off. We also provide opportunities for professional development and a supportive work environment.

Contact

If you're ready to make a difference and join our team, please submit your application with your full name, email address, phone number, LinkedIn profile (optional), and your resume (.docx, pdf).