Quality Engineer, Manufacturing Operations

About the Role

As a Quality Engineer, Manufacturing Operations in Mahwah, NJ , you will support quality assurance, quality control, and continuous improvement activities across operations and other business functions. This role focuses on maintaining product and process quality, driving preventive quality initiatives, and supporting compliance with applicable regulations, standards, and internal quality requirements. You will work cross-functionally to promote quality throughout the product lifecycle and contribute to ongoing process improvements.

What You Will Do

• Support quality assurance and quality control activities for products, processes, and manufacturing operations.
• Lead and participate in quality improvement initiatives focused on reducing defects, improving compliance, and enhancing process performance.
• Review, analyze, and investigate quality data to identify trends, risks, and opportunities for improvement.
• Apply quality engineering principles, risk-based methodologies, and statistical techniques to support decision-making and process optimization.
• Collaborate with cross-functional teams to address quality issues, implement corrective actions, and prevent recurrence.
• Ensure compliance with applicable regulatory requirements, quality standards, and internal procedures.
• Create, review, and maintain quality documentation, reports, and records in accordance with established requirements.
• Represent the Quality function in cross-functional discussions, audits, projects, and operational activities.

What You Will Need

Required Qualifications

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related engineering discipline.
• Minimum 0 years’ of experience

Preferred Qualifications

• Internship experience in quality, engineering, manufacturing, or related technical functions within regulated industries is strongly preferred.
• Experience within the medical device industry.
• Familiarity with ISO 13485, Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP).
• Knowledge of risk management methodologies and statistical analysis tools.
• Experience supporting quality systems, manufacturing quality, or process improvement activities.