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 supplier 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 communication and collaboration skills
• Detail-oriented and detail-focused
• Ability to work independently and as part of a team
• Knowledge of regulatory requirements and standards
• Experience with quality management systems
• Understanding of AI and ML methodologies

Benefits

Join a dynamic and innovative team that is making a significant impact in the field of cancer diagnostics. At BioAI, you will have the opportunity to work on cutting-edge technologies and contribute to the development of life-saving products. We offer a competitive salary, comprehensive benefits package, and a supportive work environment that values diversity and inclusion.

Pay

Competitive salary commensurate with experience and qualifications.

Schedule

Full-time position with flexible working hours to accommodate your needs.

Benefits

Health insurance, retirement plan, paid time off, and more.

Contact

To apply, please fill out the form below and upload your resume. We look forward to hearing from you!