Quality Technician I

At Tactile Medical, we specialize in developing at-home therapy devices to treat lymphedema, chronic venous insufficiency and respiratory illnesses.

At Tactile Medical, we specialize in developing at-home therapy devices to treat lymphedema, chronic venous insufficiency and respiratory illnesses. The Quality Technician I is responsible for assisting the Quality department focusing on post market surveillance reporting requirements. This position will specialize in documenting, evaluating, dispositioning, investigating product reports and identifying field complaints. This individual will also perform inspection activities including evaluating product failures and defects resulting from incoming inspection.

Accountabilities & Responsibilities

Post Market Surveillance

• Support the complaint handling process by evaluating returned product failures to determine the cause of customer complaints


• Prepare technical reports of findings using trend analysis and other statistical methods


• Repair and/or replace components to reprocess devices for future use


• Perform experimental testing as needed to assist with root cause analysis

Product Acceptance & Investigations

• Assist with performing analysis, inspection, troubleshooting, and testing of products or components identified as non-conforming during incoming, in-process and final inspection


• Participate in the non-conforming material reporting process; including, but not limited to, documenting non-conformance description, assigning a control number, and evaluating to determine cause of the non-conformance

General Responsibilities

• Identify areas of improvement and participate in continuous improvement projects


• Perform decontamination of returned products prior to evaluation


• Perform all job duties while adhering to HIPAA requirements


• Other related duties as assigned

Qualifications

Required:

• 1+ years’ experience in the medical device industry


• AA degree or equivalent work experience in related discipline

Preferred:

• Experience with electro-mechanical devices


• ASQ Quality Technician certification or equivalent


• Experience using an ERP system

Knowledge & Skills

• Proficient with Microsoft Office tools, including Word, Excel, PowerPoint, and Outlook


• Strong organization, time management, and communication skills


• Ability to follow instructions, procedures, and good documentation practices


• Hands-on troubleshooting and product evaluation skills


• Self-starter who can work independently and collaboratively

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