Quality Engineer
- 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.
- Other duties as assigned.
- 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.
- 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.
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