What are the responsibilities and job description for the Senior Quality Engineer position at ACE Partners?
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
Salary : $115,000 - $130,000
