Quality Assurance Engineer
Summary
On-site Quality Engineer at a manufacturer, supporting quality control of in-house manufactured products on the shop floor: defect identification and prevention, root cause analysis, quality KPIs, and document control while working with operators, R&D, and Operations. Requires ~3-5 years in a Quality role, quality methods (DMAIC, SPC, CPK, CAPA), and MS Office; ~10% travel.
JOB DESCRIPTION:
The Quality Engineer is responsible for supporting the quality control of all in house manufactured finished products. This is a very tactically focused problem-solving role that works directly with operators to support production. This position interacts with research and development team and Operations as part of the broader quality team
JOB RESPONSIBILITIES:
In this role you will:
Focuses on defect identification, prevention, and elimination of defect on the shop floor
Creates factory level KPI’s to support OEE and operator engagement
Communicates/Tracks/Reports defect reduction efforts across organization
Supports the non-conforming material process (identification/segregation/disposition)
Works with inspectors to lead containment activity on shop floor and warehouse as needed
Participates on NPD teams to support the transition of products to the shop floor
Maintains detailed reports related quality performance
Communicates with Operations to identify quality issues and provide guidance and lead process enhancements and improvements projects
Facilitates problem solving and root cause analysis to eliminate recurrence of non-conformance
Establishes and monitors quality KPI’s across the factory and leads improvement projects
Performs document control processes to ensure all procedures are properly documented, updated as needed and in compliance with regulatory requirements.
Participates in pilot and/or first product runs to identify potential quality issues
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
KNOWLEDGE, SKILLS, AND ABILITIES:
Ability to manage multiple projects/activities; results driven
Excellent communication and interpersonal skills.
Proficiency with MS Office Products (Word, Excel, PowerPoint, etc.)
Working knowledge of basic quality topics/processes to include: DMAIC, Statistical Process Control methods and Process Capability Index (CPK), CAPA, Cause and Effect Analysis, Pareto Analysis, etc.
EDUCATION:
BS/BA in related discipline, or equivalent combination of education and experience.
Certification may be required in some areas.
Typically, 3-5 years of experience in a Quality role
ADDITIONAL DESIRED RELATED SKILLS:
ASQ Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA), Six Sigma Green or Black belt is a plus
Knowledge of applicable Quality System requirements (GMP and ISO 9001) is strongly desired
PHYSICAL REQUIRMENTS
Extended periods of sitting and operating computers and office equipment.
Extended periods standing performing inspection activities.
May climb stairs multiple times per day.
Occasional lifting of 50 pounds.
WORK LOCATION: Somers, WI
EMPLOYEMENT STATUS: Full Time
TRAVEL REQUIRED: 10%