What are the responsibilities and job description for the Principal Quality Engineer position at ACE Partners?
Medical Devices - Principal Quality Engineer - $150k - $190k
Boston, MA
US Citizens or Green card holders only
A clinical stage medical device company, pioneering the development of long-term therapy for patients with heart failure.
The Principal Quality Engineer will play a pivotal role in investigating, planning, and implementing improvements in and/or additions to current products and manufacturing processes. You will implement a robust Quality Management System (QMS), oversee inspections, validation, and compliance with ISO 13485 and FDA regulations.
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.
- Collaborate with suppliers to establish quality agreements, conduct audits, and develop control plans.
- Lead in implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
- 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.
- 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.
- 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.
- 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.
Salary : $150,000 - $190,000
