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.

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

Required:

• Bachelors' degree or higher in Engineering/Science in Engineering Management/Mechanical/Manufacturing/Industrial Engineering or related field with 2+ years' experience
• Has knowledge of commonly used concepts, practices, and procedures within the field, including regulatory affairs.
• Ability to problem solve, identify errors and deficiencies, and perform research with general guidance.
• Ability to apply knowledge to their job function using pre-established guidelines and instructions
• Accuracy, attention to detail, and thoroughness
• Proficient computer skills
• Proficient communications skills
• Ability to comprehend and comply with company safety and quality standards
• Ability to follow oral and written instructions
• Responsible for understanding and complying with all SPG and Dupont safety policies and procedures.

Preferred:

• Previous experience in Quality Assurance
• Rudimentary knowledge of statistics
• Medical device experience
• Lean Six sigma Green Belt certification or higher desired.
• Knowledge of GD&T and ISO 13495:2016 standards
• Experience in using precision measurement tools like Vision systems, optical microscopes etc.
• Experience working in ISO Class 8 cleanroom environment.
• Knowledgeable of Control Plans, DOE, FMEA, SPC, and other lean six sigma tools
• Excellent verbal, technical writing, interpersonal and organizational skills required.

WORKING CONDITIONS:

Works under immediate supervision. Primary job functions do not typically require exercising independent judgment. This position requires about 50% of time spent sitting and working on computer. The other 50% of time would be spent moving around on the Production floor where protective clothing is necessary.