- 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
- 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
- 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
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Quality Engineer - Hermann, United States - Spectrum Plastics Master
![Default job background](https://contents.bebee.com/public/img/bg-user-ex-1.jpg)
Description
Job DetailsLevel
Entry
Job Location
Laser Light - Hermann - Hermann, MO
Position Type
Full Time
Education Level
4 Year Degree
Job Shift
Day
Job Category
Engineering
Description
ESSENTIAL DUTIES AND RESPONSIBILITIES
EDUCATION and EXPERIENCE