The Quality Engineer assists in the design and implementation of policies and procedures for testing and evaluating the precision and accuracy of products and/or equipment. This position expected to provide support to Operations, interact with customers, and provide support for Engineering, Quality Systems and Process engineering.
EDUCATION & EXPERIENCE: Bachelor’s degree required with 3-5 years of experience in manufacturing, medical device preferred
• Provide customer related quality and regulatory inquiries support
• Maintain company compliance with FDA Quality System Regulations and ISO 13485 standards.
• Lead and provide Project Management support as needed
• Direct support for FDA and ISO inspections and registration
• Support and Participate in Continuous Improvement activities
• Actively participates in internal audits, management review and other activities covered under Viant's Quality Manual, Policies and Procedures
• Compiles and writes training material and conducts training sessions on quality control activities
• Provide QE direction, analysis and recommendations for Product Development to successfully launch new products into active production in a timely and cost effective manner. Directs development and maintenance of internal/external standards relative to Design and Development,
• Lead implementation of continuous improvement projects or act as subject matter expert for SPC, FMEA, DOE and process validation.
• Develops and initiates standard methods for inspection, testing, and evaluation, utilizing knowledge in related engineering fields
• Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data
• Performs measurement system analyses to evaluate test and inspection equipment
• Leads disposition of discrepant material and devises process to assess product quality and reliability
• Monitors and directs engineering group on calibration requirements and implementation of systems to support equipment calibration
• Lead supplier approval and qualification of new/revised items which includes inspection method development and validation as well as correlation with supplier’s methods, supplier audits, management of supplier corrective and preventative actions and assist in FMEA
• Support and Participate in activities that increase the ratio of value added to non-value added processes
• Demonstrates leadership through mentoring of junior staff and responsiveness to business needs to achieve positive results
• Demonstrates technical ability through the application of engineering skills , approaches and knowledge