Quality Technician I

Job Description

Job Purpose:

• Assist Complaint Investigation Site (CIS) in receiving and decontaminating product returns. Reviews product return information and ensures proper documentation within the complaint management system. Coordinates shipment of returned devices to external vendors. May assist in the investigation and disposition of NCEP/CAPAs and participate in continuous improvement projects.
• This position does not require Medical Surveillance:
• Note, they will have exposure to blood when removing contents from packaging. Candidate must be comfortable with this.

Key Responsibilities:

• Receive product returns in Global Complaint Management System
• Perform Decontamination of return product per Work Instructions
• Pack, document, and ship out returned devices to external vendors
• Track and order supplies for laboratory
• Dispose of bio-hazardous materials per procedure
• Facilitation of Work In-Progress (WIP) management
• Organization of products for storage and disposal of product after required retention time
• Participate in continuous improvement projects
• Assist in the investigation and disposition of NCEPs and CAPAs

Quality Systems Duties and Responsibilities:

• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Qualifications:

• High school degree/equivalent with 3 years’ experience, or an equivalent combination of education/work experience
• Lab experience
• Knowledgeable in Quality System Regulations, Medical Device Directive and ISO13485 Quality Standards.
• Proficient in technical writing skills and communications
• Proficient computer skills using Microsoft Office Suite, specifically Outlook, Word, and Excel.
• Direct experience in med device complaint handling
• Someone with experience mixing chemicals
• General lab experience
• This position will be working with explanted returns
• Must be self-motivated
• Team player
• Attention to detail

Preferred Qualifications:

• Good organizational, listening, and verbal / written communication skills with demonstrated ability to follow instructions and processes
• Able to be proactive and self-motivated
• Able to interact and communicate with all levels of staff
• Demonstrates thorough attention to detail