Senior Quality Engineer (Quality Lead

TrackX Technology, Inc. is seeking an experienced Quality Engineering Leader to serve as the primary owner of quality operations and quality system effectiveness. This role will lead quality engineering activities, maintain and continuously improve the Quality Management System (QMS), and provide quality leadership across manufacturing, engineering, suppliers, and service operations.

The Quality Leader will be responsible for supplier quality, NPI quality planning, validation strategy, CAPA, complaint handling, internal audits, risk management, and regulatory compliance activities supporting medical device products. This position serves as the quality authority within the organization and partners closely with Operations and Engineering leadership to ensure products are safe, effective, compliant, and manufactured consistently.

The ideal candidate has experience leading quality functions in an ISO 13485/FDA-regulated environment and has successfully supported growing organizations where quality systems, manufacturing processes, and regulatory requirements are evolving.

This full-time, salaried (exempt), on-site position will report to the Director of Operations and be required to work from our corporate office in Hillsborough, NC.

• Own and maintain the effectiveness of the Quality Management System (QMS) and serve as the primary quality representative for internal and external quality activities.
• Serve as the quality authority for product and process decisions, with the responsibility to identify quality risks, place nonconforming product on hold, and elevate product compliance concerns to leadership.
• Ensure compliance with ISO 13485, FDA Quality System Regulation (21 CFR Part 820), and applicable regulatory requirements.
• Own Supplier Quality activities including supplier qualification, monitoring, and performance improvement.
• Lead quality efforts supporting New Product Introduction (NPI) and design transfer activities.
• Own CAPA and Nonconformance Reporting (NCR) processes from initiation through closure, including root cause analysis, corrective action implementation, and effectiveness verification.
• Conduct and oversee complaint investigations and root cause analysis.
• Maintain and execute the internal audit program, ensuring timely identification and resolution of quality system deficiencies.
• Monitor NCR aging and drive timely resolution.
• Establish validation strategies for manufacturing and quality processes.
• Develop and report key quality metrics to management.
• Lead cross-functional investigations using structured problem-solving methodologies.
• Drive supplier quality improvement initiatives.
• Support manufacturing process improvements and yield enhancement projects.
• Collaborate with engineering during product transfers and change implementation.

• Oversee quality system documentation, including procedures, work instructions, quality records, and training requirements.
• Ensure quality activities comply with applicable regulatory requirements and company procedures.
• Participate in management reviews and quality planning activities.
• Provide mentorship and guidance to junior quality personnel.

• Bachelor's degree in Engineering, Quality, Manufacturing, or related discipline.
• 7+ years of progressive experience in Quality Engineering, Quality Systems, or Quality Management within medical device, aerospace or similarly regulated industries
• Demonstrated experience owning or significantly supporting an ISO 13485/FDA-compliant QMS.
• Experience managing CAPA systems and ensuring effectiveness verification.
• Ability to independently make quality decisions and elevate quality risks to leadership.

• Experience supporting regulatory submissions, FDA communications, and interactions with regulatory agencies.
• Experience leading or supporting external audits, regulatory inspections, and quality system assessments.
• Strong working knowledge of ISO 13485, FDA Quality System Regulation (21 CFR Part 820), and medical device risk management principles.
• Experience implementing, scaling, or improving quality systems within a growing organization.

• Competitive salary, bonus potential, and equity
• 100% paid health insurance for employees. Competitive rates for family plans.
• 401k plan
• Paid holidays and PTO

TrackX Technology, Inc. is dedicated to developing state-of-the-art imaging solutions that enhance surgical precision and efficiency. Specializing in areas such as pedicle screw placement and ortho trauma, our innovative tools enable real-time instrument tracking and visualization of live fluoroscopy. By minimizing radiation exposure, reducing x-ray usage, and optimizing localization time, we strive to provide significant value to surgeons, hospitals, and operating rooms.

Our mission is to simplify and innovate surgical navigation to improve patient…