Quality Engineer I

JOB PURPOSE :

To ensure on-going product quality through implementation of quality system processes and procedures.

ESSENTIAL DUTIES :

• Ensure that the organization’s Quality management System conforms to customer, internal, 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 in preparing for 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 develop quality assurance plans for new customers and improve 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 procedures, 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 to increase the supplier / internal process capability of consistently meeting ISO and regulatory requirements.
• Leading projects including 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.
• Implements improvements using the CAPA system.
• Prepares written protocols and reports.
• Responsible for managing and scheduling the routine sterilization validations.
• Writing, reviewing, approving sterilization technical protocols and report.
• Assists with maintaining established departmental policies and procedures, objectives, and quality improvement, safety, and environmental standards.
• Upholds SPG and Dupont vision and core values.
• Performs other duties as required.