Quality Engineer III - $115 - $130k

US Citizens and Green card holders only

A clinical stage medical device company, pioneering the development of long-term therapy for patience with biventricular heart failure.

The Quality Engineer III (QE III) ensures the manufacturing, testing, and distribution of a cutting-edge Total Artificial Heart (TAH) meet the highest standards. They implement a robust Quality Management System (QMS), oversee inspections, validation, and compliance with ISO 13485 and FDA regulations. Collaborating with cross-functional teams, they address product issues, manage supplier quality, and drive continuous improvement.

Key Responsibilities

• Perform inspections on components and subassemblies, ensuring compliance with approved specifications and procedures.
• Develop and implement processes to enhance product and process quality, including planning for product and service development, material control, acceptance activities, and measurement systems.
• Investigate and resolve non-conformities related to products, processes, and quality systems, providing updates to the executive team.
• Compile, review, and approve Device History Records.
• Collaborate with suppliers to establish quality agreements, conduct audits, and develop control plans.
• Support validation activities for new facilities, materials, equipment, and processes, including test method validations and clean room maintenance (Class 8 minimum).
• Coordinate sterilization validation and ensure compliance with cleanroom standards.
• Create, revise, and maintain documentation related to design controls, quality systems, and regulatory compliance.
• Assist with regulatory submission documentation for IDE human clinical studies and ensure compliance with ISO 14971 Risk Management standards.
• Provide training and guidance to team members on quality management tools and practices, promoting awareness of the Quality System throughout the organization.
• Participate in external audits and develop responses to queries during and after audits.

Requirements

• Bachelor’s degree (or higher) in Biomedical Engineering or a related field, with 8+ years of experience in medical device development or quality assurance.
• A minimum of 5 years’ experience in a Class II or III medical device environment; experience with ventricular assist devices is highly desirable.
• Expertise in electrical and mechanical systems for medical devices in regulated environments.
• Strong knowledge of design control requirements, verification, and validation processes.
• Comprehensive understanding of quality principles, tools, and standards, including statistical analysis, risk management, and reliability.
• Working knowledge of quality systems, risk management tools, and standards, such as FMEA, ISO 14708, ISO 17025, ISO 14971, ISO 13485, and 21 CFR Part 820, 803, and 806.
• Proficiency with precision inspection equipment and tools.
• Experience across all product lifecycle phases, from conception to commercialization, in a Design Assurance role.
• Proficiency in Microsoft Office, with experience in project planning software and DAQ systems. Familiarity with MATLAB is a plus.
• Professional certifications from the American Society for Quality (e.g., CQE, CRE, CSQE, or CBA) are desirable.