Overview

The Quality Technician 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.

Responsibilities

Post Market Surveillance

• Support the Complaint Handling process by evaluating returned product failures in order to determine the cause of customer complaints
• Prepare technical reports of findings using trend analysis and other statistical methods
• Repair and/or replace components in order 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

• Identify areas of improvement and participate in continuous improvement projects
• Perform decontamination of returned products prior to evaluation
• Other duties as assigned
• Complete all job duties while adhering to HIPAA requirements

Qualifications

Education & Experience

Required:

• 2 years’ experience in the medical device industry
• AA degree or equivalent work experience in related discipline

Preferred:

• Experience with electro-mechanical devices

Knowledge & Skills

• Proficient with Microsoft Office tools including Word, Excel, PowerPoint and Outlook
• Good organizational, listening and verbal/written communication skills with demonstrated ability to follow instructions and processes
• Strong ability to successfully multi-task and adaptability
• Ability to follow good documentation practices
• Strong organizational and time management skills
• Ability to have a hands-on approach
• Self-starter with the ability to identify improvement opportunities
• Able to work independently under limited supervision as well as in a team environment
• Able to read, understand and communicate procedural requirements

Competencies

• Change Agent
• Functional/Technical Skills
• Communication
• Process oriented
• Priority Setting
• Peer Relationships
• Problem Solving
• Teamwork
• Flexible