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Quality Assurance Engineer
3 months ago
Position Overview
Join our dynamic startup team as a Quality Assurance Engineer, where you will play a crucial role in ensuring the quality and reliability of groundbreaking medical devices and digital health solutions.
In your role as a Quality Assurance Engineer, you will primarily develop and manage the various facets of the quality management system, such as CAPA, non-conformance reporting, incoming, in-process, and final inspections, complaint handling, root-cause analysis, metric generation, and be actively involved in both internal and external audits. Additionally, as a key member of our cross-functional team, you will contribute to constructing, evaluating, and appraising the outcomes of product development, encompassing user needs, design and development plans, usability, requirements, design documentation, risk management files, and verification and validation artifacts. Your role is to ensure that these elements align seamlessly with established procedures, standards, and regulatory requirements.
Key Responsibilities
1. Develop and maintain manuals, procedures, work instructions, and forms across the quality management system. Administer the Master Document List and maintain the document change request log.
2. Review and assess project work, including plans, goals, metrics, specifications, test protocols, and risk management documents, ensuring alignment with applicable procedures, standards, and regulatory requirements.
3. Provide direction and leadership for the quality of digital health technologies, guiding the establishment of product and software requirements, specifications, detailed design, verification, validation, and usability protocols.
4. Collaborate with project teams to ensure compliance with global ISO standards (ISO 13485, ISO 14971, IEC 6060-1, and IEC 62304), regulations (e.g., 21 CFR Part 820, 21 CFR Part 11, MDD/MDR), and applicable guidance.
5. Represent quality in technical design reviews, project phase reviews, and problem resolution activities.
6. Participate in internal and external audits, ensuring the continued suitability and effectiveness of the quality management system.
7. Interface with customers on quality-related issues.
Qualifications
Education:
Bachelor's degree in Science, Engineering, Systems Engineering, or Biomedical Engineering
Experience and Skills:
4 years of experience with a focus on design control, risk management, and verification and validation.
4 years of Quality experience within the medical device, aerospace, defense, or similarly regulated industry.
Experience with Data Science and Advanced Statistical Techniques.
Strong verbal and written communication skills; ability to present issues, plans, and objectives.
Excellent organizational, problem-solving, and analytical skills.
Ability to lead priorities and workflow with versatility, flexibility, and a willingness to work within a constantly evolving environment.
Preferred:
Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1, IEC 62304, FDA's General Principles of Software Validation.
Passion for the development and execution of new technologies, including the ability to apply and manage design controls within emerging technologies.
Join us, a startup with young and talented minds, and contribute to the advancement of technology in the medical field. We are seeking professionals who share our passion and are eager to be part of an innovative and expanding team.
