Job Title: Principal Quality Engineer

Work Location: Middlesex County, Massachusetts

Summary:

Seeking an experienced Principal Quality Engineer to support new product development and quality assurance activities in a complex engineering environment focused on advanced medical device systems. This role involves leading quality initiatives, risk management, and compliance processes to ensure product excellence and regulatory adherence.

Responsibilities:

• Guide quality engineering efforts throughout the design phase, including development, verification, validation, transfer, and design reviews for new product development.
• Lead risk management activities, including analysis and documentation, across the product development lifecycle.
• Support cross-functional engineering teams in software, data science, and hardware/systems through design control and software development life cycle processes.
• Oversee operational quality activities such as material control, process development, inspection, nonconforming material management, equipment qualification, and supplier oversight.
• Conduct inspections and testing of materials, equipment, processes, and products to ensure compliance with quality specifications.
• Develop and implement quality system processes to meet regulatory standards and ensure ongoing compliance.
• Provide training and mentorship to personnel on quality and compliance best practices, fostering continuous improvement.
• Manage internal audit activities and ensure readiness for external certification audits, while expanding knowledge of relevant external standards for product commercialization.

Qualifications:

• Bachelor's degree in mechanical engineering, biomedical engineering, or a related engineering field.
• At least 10 years of experience in quality engineering or a related role within a regulated industry.
• Experience with software, data science, hardware/systems design and production, or similar medical devices within a Quality Management System.
• Applied knowledge of 21 CFR 820, ISO 13485:2016, and IEC 62304:2006 standards.
• Demonstrated expertise in product development lifecycle, software development life cycle, design controls, and risk analysis.
• Strong communication skills, proficiency in documentation practices, attention to detail, and project management abilities.

Published Category: Quality & Validation