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
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