Quality Engineer

Job Description

Job Title : Quality Engineer

Location : Denville, NJ

Position Overview

The Quality Engineer will play a key role in supporting laboratory qualification, equipment calibration, preventive maintenance, and product release activities. This position involves writing and executing protocols, supporting inspections, and ensuring compliance with medical device quality and regulatory standards.

Key Responsibilities

• Develop and execute procedures for incoming, in-process, and final inspections, as well as product release activities.
• Interpret engineering drawings and determine appropriate inspection and gauging methods (e.g., first article inspections).
• Support lab qualification and validation activities, including calibration and preventive maintenance of testing equipment.
• Maintain and manage calibration systems, GMP documentation, and training records.
• Collect, analyze, and report quality performance metrics.
• Support internal audits, management reviews, and other quality system initiatives.
• Collaborate with cross-functional teams to ensure compliance with FDA QSR, ISO 9001, and ISO 13485 standards.
• Perform lab testing and assist with batch release verification at internal and external manufacturing sites.
• Participate in supplier audits and project-related quality support as needed.

Qualifications & Experience