Linde Gas Equipment Inc.

Quality Assurance Specialist

Location: Livingston, TN

Linde Gas Equipment Inc. is seeking a Quality Assurance Specialist to join our team

This role will be responsible for supporting the Livingston, TN Service Center in all aspects of product repair, maintenance, and release of Medical Devices performed in accordance with FDA’s applicable regulations and applicable standard operating procedures (e.g., 21 CFR Part 820, ISO 13485, and the local QMS). The Quality Assurance Associate will handle the Quality inspection of Device repair records, complaints investigations, and non-conformances, trend analysis, and reporting. The Quality Assurance Associate will have the ability to work independently and to provide consultative advice within specific areas of expertise.

What we offer you

Competitive compensationComprehensive benefits plan (medical, dental, vision and more)401(k) retirement savings plan Paid time off (vacation, holidays, PTO)Employee discount programsCareer growth opportunities

What you will be doing:

Perform quality control reviews of service and repair checklists ensuring all serviced/ repaired units are confirmed as meeting specification. Resolve any documentation issues and perform QC approval of devices to be returned to stock.Raise any quality or technical concerns with facility management and the LGE national quality department to ensure they are resolved in a prompt manner.Ensuring procedures relating to service and repair are followed and maintained, ensure control of quarantine, and reject items.Monitoring of devices returned for repair/service for possible complaints and supporting the LGE national quality with the investigation of potential complaints.Generate calibration certificates/ release certificates following device repairs.Author, maintain, and ensure compliance to technical documentation such as work instructions, forms/records, logbooks, etc.Train facility personnel on Quality Management Procedures and quality principles. Assists in maintenance of training schedules and training records systems.Participate in the completion of Change Controls.Assists in internal and supplier audits and establishing/updating supplier and component specifications and testing as needed. Participate in and support external audits conducted by regulatory bodies and registrars.Assist with the investigation and documentation of nonconformances, deviations, and CAPAs (Corrective and Preventive Actions), ensuring timely and effective resolution.Maintain safe working practices around gas and gas products. Adhere to all Health and Safety guidelines appropriate to the role and maintain a safe working environment.Other duties as assigned