Quality Assurance - QUALITY ENGINEER TECHNICIAN

MAIN PURPOSE OF JOB:

Quality assists in the design and implementation of policies and procedures for testing and evaluating the precision and accuracy of products and/or equipment. The Quality Engineering Technician will be expected to provide support to Operations, interact with customers and provide support for Engineering, Quality Systems and Process engineering. This position will be integral in meeting the Quality Management System requirements. It requires creativity and foresight to work with operations and product development teams to ensure compliance to the Quality Manual, Design Control, Supplier Management and other appropriate procedures for a variety of medical devices in a sustaining position.

MAIN JOB RESPONSIBILITIES:

• Exhibits the Viant Medical Values in all activities
• Maintain company compliance with FDA Quality System Regulations and ISO 13485 standards.
• Actively participates in internal audits (Auditee in training) with a willingness to train and/or obtain a Lead certification
• Provide Site Production Support via QE (Technician Level) direction for Nonconformance’s, Change Control and Release Activities
• Provide customer related quality and regulatory inquiries support
• Support and participate in implementation of continuous improvement projects/activities
• Support the Development and initiation of standard methods for inspection, testing, and evaluation, utilizing knowledge in related engineering fields
• Facilitate execution of measurement system analyses under Engineering Direction to evaluate test and inspection equipment
• Supports disposition of discrepant material and devises process to assess product quality and reliability under Quality Engineering Direction
• Support for FDA and ISO inspections, audits, and registration
• Support and Participate in activities that increase the ratio of value added to non-value added processes
• Demonstrates willingness to learn and be agile under Engineering Direction through mentoring and responsiveness to business needs to achieve positive results
• Demonstrates Junior level technical ability through the application of Engineering Technician skills, approaches and knowledge

All other duties, as assigned