Koya Medical Quality Technician Dallas, TX · Full time Company website

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The Role

The Returns Technician will provide hands-on troubleshooting and analysis of product returns and data to identify failure mechanisms at the device and system level. Through attention to detail, critical thinking, and cross-team collaboration, this role will drive insights and solutions that will solve real customer problems and reduce returns. 

Primary Responsibilities:

• Receive and log incoming returns. Maintain accurate ERP records by tracking material both physically and in ERP
• Using written procedures and equipment such as digital multimeters, custom fixtures, and hand tools, troubleshoot devices (hardware, software, connected devices) to identify true failure mechanism
• Document, report and track failure mechanisms and their return rate impact
• Gather and analyze device failure data to identify trends; report data to cross functional teams and use trends to drive priorities and problem solving.
• Record and scrap defective/damaged devices according to established procedures
• Submit return and exchange orders in ERP to be shipped to customers
• Refurbish usable devices per written procedures
• Continuously improve processes and work instructions

Competencies

• Proven critical thinking and problem-solving skills
• Exceptional attention to detail and accuracy
• Proven track record within troubleshooting and identification of failure mechanisms
• High persistence, drive and passion to understand underlying issues with product
• Self-driven, hands-on, curious minded, goes beyond expectations and has a “can do” attitude and entrepreneurial spirit
• Quickly establishes network with peers across the organization to drive investigations all the way through
• Ability to prioritize and manage multiple responsibilities simultaneously and follow through in a timely manner
• Customer focused, passionate & purpose driven; strong motivation to improve product quality and reliability

Requirements

• A Bachelor’s degree and 1 year of experience are preferred or an equivalent of combined education and work experience
• Working knowledge of ISO 13485:2016 and FDA regulations applicable to medical devices is preferred
• Experience working with Microsoft Excel and software such as ERP or eQMS systems
• Ability to use hand tools including scissors, tweezers, screw drivers, electrical probes, and other similar tools
• Location: Onsite at Koya Medical’s Oakland facility
• Working Environment: Manufacturing facility and office environment
• Physical Demands: Sitting, standing, lifting, bending, reaching, no more than 20 lbs.
• Position Type and Expected Hours of Work: Full-time position + Monday-Friday