- Location
- Winston-Salem, NC, US
- Type
- Full-time
- Department
- Engineering
- Closing date
- Today
- Source
- iCIMS
Description
Overview
THE ROLE:
The First Shift Quality Engineering Technician will be part of the Quality Engineering team at Herbalife Innovation & Manufacturing, Winston-Salem, NC. This individual will be responsible for maintaining compliance around product quality complaint investigations using the Product Quality Module (PQM) of the Agile Information System (Agile) and involved in tracking, trending and reporting of Quality Issues as well as completing Root Cause Analyses.
HOW YOU WOULD CONTRIBUTE:
- Maintain a working knowledge of regulatory and Herbalife guideline requirements.
- Process and analyze product customer complaints according to internal Standard Operating Procedures (SOPs) and product specifications. Conduct product complaint investigations to determine possible root cause and corrective / preventative actions. These investigations will include, but are not limited to, manufacturing/packaging batch record review, COA review and inspection of retain samples.
- Perform tracking / trend analysis and report analysis to management as appropriate.
- Receive and log Non-conforming Material Reports (NMRs). Follow up and assist in investigating / determining root cause for non-conforming product and report out findings to the material review board. Close out and document the disposition of the NMR.
- Routing manager for Material Review Reports (MRR)
- Perform lot genealogy investigations for management upon request
- Draft rework protocols for packaging operations
- Hold cross-functional quality review meetings
- Assist in implementing corrective or preventative actions (CAPA) to ensure product quality.
- Perform other related duties as assigned by management.
- Maintain performance metrics to facilitate the review of program/product effectiveness, efficacy, and actions for adherence to quality.
- Conduct Non-Conformance investigations to determine possible root causes and corrective / preventative actions for issues found at the distribution centers.
SUPERVISORY RESPONSIBILITIES:• None
Job Qualifications
SKILLS AND BACKGROUND REQUIRED TO BE SUCCESSFUL:
Skills:
- Excellent written and communication skills
- Strong investigative skills
- Knowledge of Good Manufacturing Practices, Food and Drug Administration (FDA) regulations (FDA 21 CFR – Part 111) and documentation procedures.
- Must be capable of organizing data from multiple sources, extracting key information and documenting investigation detail.
- Demonstrated ability to be self-motivated as well as to work collaboratively in a team-based environment is required.
- Must demonstrate initiative and a willingness to learn
- Strong computer skills
- Proficient in Microsoft Office Applications
- Contributes to team by maintaining a positive outlook.
Experience:
- See the ‘Education’ section.
Education:
- A minimum of BA/BS degree in a Life Science, Engineering, or Physical Science and 1+ years’ experience in a quality / regulatory environment.
- 5+ years of applicable experience will be considered in lieu of a degree.
PREFERRED QUALIFICATIONS:
- Experience using data analysis computer tools and statistical analysis
PHYSICAL DEMANDS:
In general, the following physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to allow otherwise qualified individuals to perform the essential functions of the job.
Must be able to see, hear, speak and write clearly in order to communicate with employees and/or other customers.Manual dexterity required.
Moderate: Mostly standing, walking, bending, frequent lifting
WORK ENVIRONMENT:
In general, the following conditions of the work environment are representative of those that an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job within the environment.
The manufacturing facility is clean, orderly, properly lighted and ventilatedNoise levels are considered low to moderate, with some areas requiring hearing protection
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