Quality Engineer

Full-time/Direct Hire/In Office Position

This role plays a critical part in ensuring that assemblies and products meet rigorous dimensional, functional, and visual specifications in a highly regulated environment. The Quality Inspection Engineer will contribute both strategically and hands‑on, supporting and executing inspection activities while helping uphold a culture of precision, accountability, and continuous improvement. This individual must bring strong technical judgment, exceptional attention to detail, and a proactive approach to problem‑solving.

The role also includes direct interaction with customers and occasional regulatory representatives, requiring professionalism, confidence, and the ability to communicate quality standards clearly and effectively.

The organization is an established, certified third‑party partner to small‑to‑mid‑sized medical device companies, providing specialized quality inspection, manufacturing support, and customized fulfillment services. Operating at a critical point in the medical device lifecycle, the team ensures products meet stringent quality and compliance standards before returning to the field. The facility is purpose‑built to receive, process, inspect, and prepare medical devices for return to the field in accordance with regulatory requirements, serving as a trusted extension of clients’ quality and operational functions.

• Create and revise standard operating procedures (SOPs) and work instructions.
• Develop, validate, and document test methods.
• Conduct training of quality inspectors.
• Assure all quality inspection operations are performed in accordance with procedures.
• Provide technical support to quality inspections team.
• Track recurring issues and escalate as needed to achieve root cause and corrective action.
• Interface daily with customers to provide status of open issues and drive those items to closure.
• Handle materials in accordance with procedures and maintain traceability of component materials as to inspection status.
• Interface with a cross‑functional team to drive improvements in inspections area.
• Update Quality Inspection procedures and Inspection plans as needed.
• Investigate customer complaints and SCARs.
• Other responsibilities as required.

• Bachelor’s degree in engineering or similar field
• 1‑2+ years of experience in manufacturing quality control/inspection
• Experience with reading and understanding drawings, blueprints, piece prints, and GD&T
• Ability to lift and move up to 50 pounds

• Experience with software development and validation
• Experience in Medical Device Quality or similar regulated field
• CMM programming capabilities

Pay is commensurate with experience with a competitive benefits package.