Quality Engineer

Job Title : Service Quality Engineer

Job Type : Permanent

Location : Morristown, NJ

A world-leading medical technology company developing innovative solutions are seeking a motivated Service Quality Engineer to join the team as part of its global expansion. This is an opportunity to work in an innovative, fast-paced global medical device organization committed to improving patient outcomes. The role of Service Quality Engineer is responsible for ensuring the delivery of exceptional service quality for our Class IIa medical device products. The successful candidate will play a critical role in maintaining compliance with regulatory requirements, driving continuous improvement, and ensuring customer satisfaction through effective service quality management.

Responsibilities :

• Oversee and maintain the quality of services related to Class IIa medical devices, ensuring compliance with ISO 13485, EU MDR, FDA 21 CFR Part 820, and other applicable regulatory standards.
• Develop and implement service quality procedures, policies, and processes.
• Monitor and evaluate field service activities to ensure adherence to quality standards.
• Conduct root cause analysis for service-related nonconformities and implement corrective and preventive actions (CAPAs).
• Maintain detailed records of service quality activities, complaints, and resolutions in compliance with regulatory requirements.
• Support internal and external audits, including preparation and follow-up activities.
• Analyze service quality metrics, customer feedback, and complaint trends to identify opportunities for improvement.
• Lead or participate in projects to enhance service quality and customer satisfaction.
• Develop and monitor KPIs to measure service performance and effectiveness.
• Act as a point of contact for escalated service quality concerns.
• Liaise with customers and service teams to address quality issues and ensure swift resolution.

Responsibilities :