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JOB DESCRIPTION:

The Quality Engineer I will support quality engineering functions in a high-tech manufacturing environment. They will ensure compliance to quality management system by monitoring and improving reliability of new and existing processes, maintain company quality standards, oversee the product manufacturing process and suppliers to ensure quality, and participate in all quality improvement efforts.

KEY RESPONSIB ILITIES:

+ Ensure that the organization’s Quality management System conforms to customer, internal, ISO 9001:2015, ISO 13485:2016 and regulatory/legal requirements.

+ Support in Electronic Quality Management System functions and assist in managing modules that control relevant quality functions.

+ Participate in process and product inspections, supporting decisions on inspection methods, sampling plans, and inspection equipment.

+ Assist 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 under the guidance of senior engineers to support quality/continuous improvement projects.

+ Assist in developing quality assurance plans for new customers and improving process efficiency for existing customers.

+ Assist 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

+ Assist in supplier / internal process improvement projects to increase the supplier/internal process capability of consistently meeting ISO and regulatory requirements.

+ Support projects including process analysis, value stream mapping, process capability and throughput analysis, DOE, 6‐Sigma, 5S and Kaizen events.

+ Assist in Supplier Quality Reviews as directed.

+ Programming CMMs and other measurement gages to customer drawings

+ Assist maintenance department with external and internal calibration of critical measuring equipment.

+ Assist in internal and external validation/verification of processes.

+ Assist in audits which includes ISO 9001:2015, 13485:2016 Internal, External, supplier and Customer audits.

+ Responsible for understanding and complying with all SPG and Dupont safety policies and procedures

Qualifications

QUALIFICATIONS: (Education/Experience/Knowledge, Skills & Abilities)

EDUCATION:

+ Bachelors’ degree or higher in Engineering/Science in Industrial Engineering/ Mechanical/Manufacturing/ Engineering Management or equivalent experience in a related field

REQUIRED EXPERIENCE:

+ Knowledge of modern manufacturing methods, tools, and techniques

+ Computer proficiency in Microsoft Excel, Word, PowerPoint

+ Basic knowledge of quality tools: Control Plans, PFMEA, SPC, 6-Sigma, GD&T

+ Excellent verbal, technical writing, interpersonal and organizational skills required

+ Ability to form independent conclusions related to tasks

+ Ability to problem solve

PREFERRED EXPERIENCE:

+ Knowledge of ISO 9001:2015, ISO 13485:2016 standards

+ Familiarity with data visualization tools and dashboards is a plus

+ Experience in using precision measurement tools like Vision systems, 3D profilometers, optical microscopes etc.

+ Experience working in ISO Class 5 and Class 6 cleanroom environment.

WORK ENVIRONMENT:

+ Works under general supervision.

+ In office environment and on the manufacturing plant floor.

NOTE: This job description is not intended to be an exhaustive list of all possible duties, responsibilities and or qualifications. Other duties, responsibilities and/or qualifications may be assigned to this position.