Quality Engineer

Job Title: Quality Engineer



Location: Branchburg, NJ



Duration: 12+ Months



Shift Timings: 8:00 AM to 5:00 PM

Key Responsibilities:

• Support the implementation and ongoing effectiveness of the Quality Management System.

• Provide quality and compliance support for equipment installation, automation, computer systems, manufacturing processes, and process improvement projects.

• Support qualification and validation activities, including strategy development, protocol review, execution, and documentation.

• Lead and support deviation investigations, root cause analysis, corrective actions, and CAPA activities.

• Support risk management activities across applicable quality system processes, including Design Control, Product Surveillance, and Field Actions.

• Develop, review, and maintain risk management documentation and FMEA activities.

• Perform product impact assessments for manufacturing events and determine appropriate quality actions, including product holds when required.

• Review commissioning, qualification, and validation documentation to ensure compliance with established procedures and regulatory requirements.

• Support data integrity initiatives to ensure the accuracy, security, consistency, and completeness of data.

• Review and approve SOPs and other quality documentation to ensure compliance with applicable requirements.

• Collaborate with Manufacturing, Engineering, Quality, Operations, and other cross functional teams to resolve quality issues and drive continuous improvement.

• Provide off shift support as required, including rotating evening and weekend on call coverage.

Required Qualifications:

• Bachelor's degree in Engineering, Biology, Chemistry, or a related technical field.

• 6+ years of experience in Manufacturing, Quality, or Engineering.

• Strong knowledge of Quality Management Systems and regulatory requirements.

• Experience with ISO 13485, ISO 14971, and FDA 21 CFR Part 820 or equivalent regulated quality systems.

• Strong understanding of Risk Management and FMEA.

• Demonstrated experience with technical problem solving, root cause analysis, deviations, and CAPA.

• Excellent written and verbal communication skills.

• Strong analytical, interpersonal, negotiation, and cross functional collaboration skills.

Preferred Qualifications:

• Experience in Medical Device, Pharmaceutical, Biotechnology, or other regulated manufacturing environments.

• Experience working within cGMP manufacturing environments.

• Experience with qualification, validation, and manufacturing process improvement activities.

• Experience implementing and maintaining effective Quality Management Systems.