Quality Engineer

Job Title : Quality Engineer

Location : New Jersey, USA

Job Summary :

We are seeking a highly skilled and detail-oriented Quality Engineer with a strong background in the pharmaceutical or biotech industry. The ideal candidate will be responsible for ensuring compliance with cGMP regulations, quality standards, and continuous improvement initiatives to maintain the highest product quality and regulatory compliance across manufacturing operations.

Key Responsibilities :

• Ensure compliance with FDA, cGMP, ICH, and other applicable regulatory guidelines.
• Develop, implement, and maintain Quality Systems such as CAPA, Change Control, Deviation Management, and Risk Management.
• Support process validation, equipment qualification, and method validation activities.
• Conduct internal audits and support regulatory inspections and customer audits.
• Perform root cause analysis and implement effective corrective and preventive actions (CAPA).
• Collaborate with cross-functional teams (Production, R&D, Regulatory, Engineering) to ensure product quality throughout the lifecycle.
• Review and approve batch records, SOPs, test protocols, and validation documentation.
• Participate in continuous improvement initiatives to enhance process efficiency and product quality.
• Support supplier qualification and quality risk assessments as needed.

Required Qualifications :