United Pharma Technologies Inc
Job Title:
Quality Engineer Location:
Denville, NJ
The information below covers the role requirements, expected candidate experience, and accompanying qualifications.
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 Minimum 8 years of hands-on quality engineering or inspection experience, preferably within medical device or combination product manufacturing. Strong knowledge of Quality Systems Regulations (QSR), GMP, ISO 9001, and/or ISO 13485. Experience with system documentation, inspection processes, and equipment calibration. Proficiency in Microsoft Excel and other data management tools; experience with statistical analysis is a plus. Excellent communication and organizational skills. Certifications such as CMI or CQT are preferred. Strong mathematical aptitude and attention to detail
Quality Engineer Location:
Denville, NJ
The information below covers the role requirements, expected candidate experience, and accompanying qualifications.
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 Minimum 8 years of hands-on quality engineering or inspection experience, preferably within medical device or combination product manufacturing. Strong knowledge of Quality Systems Regulations (QSR), GMP, ISO 9001, and/or ISO 13485. Experience with system documentation, inspection processes, and equipment calibration. Proficiency in Microsoft Excel and other data management tools; experience with statistical analysis is a plus. Excellent communication and organizational skills. Certifications such as CMI or CQT are preferred. Strong mathematical aptitude and attention to detail