Quality Engineer

Quality Engineer

Our client, a leading organization in the medical devices, pharmaceuticals, and biotechnology sectors, is seeking a dedicated and detail-oriented Quality Engineer to join their team. As a Quality Engineer, you will be an integral part of the Quality Assurance department, supporting cross-functional teams to uphold the highest standards of quality and compliance. The ideal candidate will demonstrate strong analytical skills, excellent communication, and a proactive approach to problem-solving, aligning successfully with the organization's commitment to excellence and innovation.

Location: Fair Lawn, NJ

Pay Range: $25

What's the Job?

• Support quality assurance activities within GMP/ISO regulated environments, ensuring compliance with industry standards.
• Participate in investigations, analyze quality data, and implement effective corrective actions to address issues.
• Develop and maintain Standard Operating Procedures (SOPs), protocols, and technical reports with precision and clarity.
• Utilize quality tools and methodologies such as risk management, root cause analysis, CAPA, and change control to improve processes.
• Collaborate across departments to build consensus, share insights, and foster a culture of continuous improvement.

What's Needed?

• Bachelor's Degree in Life Sciences, Engineering, Chemistry, or a related scientific/technical field, with at least 1 year of quality assurance experience in regulated environments.
• Knowledge of quality systems, cGMP regulations, and standards including ISO 13485 and ISO 9001.
• Experience supporting investigations, analyzing quality data, and implementing corrective actions.
• Proficiency in quality management software (e.g., TrackWise, SAP QM) and Microsoft Office Suite.
• Strong documentation, technical writing skills, and the ability to communicate effectively both verbally and in writing.

What's in it for me?

• Opportunity to work in a dynamic and innovative environment dedicated to advancing healthcare solutions.
• Engage in meaningful work that impacts patient safety and product quality.
• Collaborate with a diverse and talented team committed to excellence.
• Develop your skills through exposure to industry-leading quality practices and tools.
• Enjoy a structured work schedule Monday through Friday, 8 am to 5 pm, with potential for growth and professional development.