STAFF QLTY & RELIABILITY ENGINEER

Job Overview

This position is responsible for direct interaction, support, and customer quality management, assuring that QSRs and QMS are in accordance with regulatory standards and promote continuous improvement of the Quality System. Other duties may be assigned on an individual basis:
This position will report directly to the Quality Manager. This position has no direct reports but must serve as a mentor to technicians and inspectors in order to foster team growth and competency.
Essential Functions:

• Implementation of quality system documentation that is in compliance with the quality manual and associated Leader Standard Work (LSW) and Standard Operating Procedures (SOPs).
  
• Develop and execute to Validation Master Plans, Equipment Qualifications, Process Validations, and test method validations for successful transfer from development to manufacturing working in a cross-functional group.
  
• Develop, maintain, and improve the PFMEA and Control Plan process for manufacturing.
  
• Support/participate in regulatory agency and customer quality audits.
  
• Participate in design and process control activities to ensure that products meet specifications, reliability, and manufacturability.
  
• Working knowledge of CAPA management to drive root cause analysis and practical corrective and preventive solutions. Utilize formal problem- solving techniques to resolve product and/or process related issues.
  
• Write and or assist in development of protocols, technical investigation plans, engineering reports, and related procedures which ensure statistical validity, adequacy, and compliance to regulatory and corporate requirements.
  
• Working knowledge of concepts of probability and statistics as well as aide in updating/establishing SPC and Gage R&R studies.
  
• Work with suppliers of both raw materials and components to improve product quality and/or resolve quality issues.
  
• Provides problem solving support, clarification of process performance requirements, to successfully complete assigned tasks as directed.
  
• Manage project transfers related activities
  
• Collaborates with other Quality Engineers, Technicians, and Inspectors to ensure that:
  

o Quality Problems are detected and corrected in the earliest stages of production
o Quality Problems are not transferred downstream

• Collaborates with other functions to implement quality improvement projects per fiscal year objectives accordingly.
  

What your background should look like:

• BS/BA degree with an engineering, or business emphasis highly preferred.
  
• Certified Quality Engineer or MS degree desirable
  
• Six Sigma Green/Black belt a plus
  
• Experience with Lean Concepts preferred
  
• Minimum of 5 years’ experience in Quality related role preferred
  

Competencies