Technician, Quality Engineering

Herbalife•Winston-Salem, NC

2d•Onsite

About The Position

The Quality Engineering Technician will be part of the Quality group 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.

Requirements

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.
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.

Nice To Haves

Experience using data analysis computer tools and statistical analysis

Responsibilities

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.