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

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

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.