Job Summary

We are seeking a hands-on Quality Engineer to join our team. This role is crucial for ensuring the highest quality, safety, and effectiveness of our medical devices. You will be instrumental in both executing key quality tasks and supporting the continuous development and adherence to our Quality Management System (QMS). This is an exciting opportunity to directly impact product quality and regulatory compliance in a growing, innovative company.

Responsibilities

• Contribute to the development, implementation, and maintenance of our Quality Management System (QMS) and associated standards.
• Plan and execute incoming inspections for components and materials.
• Support and optimize production line testing of our devices to ensure consistent quality.
• Actively support design and development activities, including design reviews, verification, validation, and maintaining the Design History File (DHF) for both new and existing products.
• Participate in risk analysis and management activities in accordance with ISO 14971, ensuring product safety throughout the lifecycle.
• Investigate product complaints, reported quality issues, and nonconformities.
• Drive root cause analysis and implement effective corrective and preventive action plans (CAPAs) to prevent recurrence.
• Support supplier qualification, monitoring, and corrective actions to ensure the quality of supplied components and services.
• Develop, review, and approve essential QMS documentation, including SOPs, work instructions, test plans, protocols, and reports.
• Ensure strict adherence to medical device regulations such as FDA 21 CFR Part 820, ISO 13485, IEC 60601-1, IEC 62304. Provide quality support for regulatory submissions, including 510(k) activities.
• Prepare and maintain documentation to ensure audit readiness and support internal and external audits.
• Identify and implement opportunities for process improvement within the QMS and across the product development and manufacturing lifecycles.
• Work closely with R&D, Engineering, Manufacturing, and Regulatory Affairs teams, serving as a hands-on quality resource to integrate quality requirements effectively.

Qualifications

• Bachelor's degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related scientific discipline.
• 5 years of direct experience as a Quality Engineer in the medical device industry.
• Proven hands-on experience in developing and implementing quality systems and standards.
• Solid understanding and practical experience with medical device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, IEC 60601-1, IEC 62304, and IEC 60601-2-37.
• Demonstrated experience in planning and executing incoming inspections and production line testing of products/components.
• Experience investigating product complaints, quality issues, and nonconformities.
• Track record of developing and implementing corrective and preventive action plans (CAPAs).
• Familiarity with Design Controls, Risk Management (ISO 14971), and supporting regulatory submissions (e.g., 510(k)).
• Experience with electronic Quality Management Systems.
• Strong analytical, problem-solving, and critical thinking skills.
• Excellent communication skills, both written and verbal, for effective documentation and cross-functional collaboration.
• Highly detail-oriented with the ability to manage multiple tasks in a dynamic, fast-paced startup environment.

Preferred Qualifications:

• Experience with ultrasound devices.
• Experience with Enzyme eQMS
• ASQ Certified Quality Engineer (CQE) or other relevant quality certifications.
• Direct experience supporting a medical device product through initial manufacturing scale-up and commercial launch.

Salary : $80,000 - $130,000