Quality Engineer

Description

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Ensure that the organization’s Quality management System conforms to customer, internal, ISO 9001:2015, ISO 13485:2016 and regulatory/legal requirements.
• Be the technical expert in the Electronic Quality Management System and modules that control relevant functions
• Oversee process and product inspections that include deciding and implementing inspection methods, sampling plan and inspection equipment
• Assist to quality meetings and management review meetings to report to top management technical data regarding the performance and effectiveness of the quality management system
• Work with engineering and quality manager and lead quality/continuous improvement projects
• Work closely with the customer and developing quality assurance plans for new customers and improving process efficiency for existing customers.
• Provide support in entering of RMAs, CAPA, monitoring of DCRs and Deviations, and PPM tracking.
• Assist in document control functions by creating new operating procedure, work instructions, forms etc.
• Responsible for supporting Engineering and Manufacturing to resolve technical issues and implement corrective and preventive action (CAPA)
• Maintain KPI’s as required by Quality Management System
• Leading supplier / internal process improvement projects in an effort to increase the supplier/internal process capability of consistently meeting ISO and regulatory requirements. Projects may include: process analysis, value stream mapping, process capability and throughput analysis, DOE, 6‐Sigma, 5S and Kaizen events
• Act as the Supplier Quality Representative and conduct all Supplier Quality Reviews.
• Programming CMMs and other measurement gages to customer drawings
• Assist maintenance department with external and internal calibration of critical measuring equipment
• Manage, coordinate and assist teams for internal and external validation/verification of processes
• Assist in audits which includes ISO 9001:2015, 13485:2016 Internal, External, supplier and Customer audits
• Collaborate with external interested parties to improve Quality management system
• Other duties as assigned

Qualifications

EDUCATION and EXPERIENCE  

• Bachelors’ degree or higher in Engineering Management/Mechanical/Manufacturing/Industrial Engineering or related field with 2 years’ experience
• 2 years in Quality Engineering or related field in the industry preferred
• Prior experience and ability to read blueprint and drawings

KNOWLEDGE, SKILLS, AND ABILITIES

• Lean Six sigma Green Belt certification or higher desired
• Knowledge of GD&T and ISO 9001:2015, ISO 13495:2016 standards
• Proficiency in precision measurement tools like Vision systems, 3D profilometers, optical microscopes etc.
• Experience working in ISO Class 5 and Class 6 cleanroom environment
• Knowledgeable of Control Plans, DOE, XFMEA, SPC, and other lean six sigma tools
• Excellent verbal, technical writing, interpersonal and organizational skills required