Quality Manufacturing Engineer

Title- Quality Engineer Location: Phillipsburg, NJ - Onsite Job Summary We are seeking a Quality Engineer with 5+ years of experience in regulated manufacturing environments. The ideal candidate will support quality assurance programs, ensure compliance with cGMP, ISO, and FDA requirements, and drive continuous improvement initiatives across quality systems and processes. Key Responsibilities

• Support and maintain quality systems including CAPA, Complaint Handling, Validation, Stability, and SPC.
• Conduct root cause investigations and implement corrective and preventive actions.
• Ensure compliance with cGMP, ISO 9000, FDA, ICHQ7, and IPEC requirements.
• Participate in internal, customer, and regulatory audits.
• Investigate customer complaints and coordinate resolution activities.
• Analyze quality data and support process improvement initiatives.
• Collaborate with cross-functional teams to enhance product and process quality.

Required Qualifications

• 5+ years of Quality Engineering or Quality Assurance experience.
• Experience in Pharmaceutical, Biotechnology, Chemical, or related regulated industries.
• Strong knowledge of cGMP, ISO 9000, FDA regulations, CAPA, Validation, and Audit processes.
• Experience with complaint investigations, root cause analysis, and quality system management.
• Strong communication and problem-solving skills.