Quality Assurance Engineer I,

Herbalife•Winston-Salem, NC

1d•Onsite

About The Position

This is a high visibility Quality Assurance Engineer I role that interacts with Operations Departments to create a relationship between the two groups. The Quality Assurance Engineer I will be part of the Quality Engineering team at Herbalife Innovation & Manufacturing, Winston- Salem, NC. This individual will be responsible for performing root cause analyses and leading CAPAs for Material Reviews, Product Complaints, and Non-conforming products. The incumbent should be well versed in data driven decision making for quality defects and developing quality related projects for drive down those defects.

Requirements

Has strong knowledge of assessment tools and reporting
Strong Microsoft Office Suite skills including Microsoft Excel skills /data analysis (statistics, pivot tables, etc.)
Capable of organizing data from multiple sources, extracting key information and documenting investigation detail. Strong investigative skills.
Excellent written and communication skills
Ability to facilitate and lead group discussions
Knowledge of Good Manufacturing Practices, Food and Drug Administration (FDA) regulations (FDA 21 CFR – Part 111/117) and documentation procedures.
Proven 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.
Understands the importance of group thought, information sharing, collaboration and appropriate challenges to status quo
Demonstrates a strong desire to be involved, maintain a positive attitude, and make a meaningful difference.
3-5 years' experience in a quality/regulatory environment + 3 years' experience in Quality related field
Knowledge of basic GMP and QA/QC in the food, nutraceutical or pharmaceutical industry
Bachelor's degree in Life Science, Engineering, or Physical Science
In lieu of a degree, 7+ years of applicable experience will be considered

Nice To Haves

ASQ Quality Engineer Certification
Six Sigma Yellow and Green Belt
BS or MS Degree in Quality Engineering
Process Control Qualified Individual (PCQI)
Better Process Control School (Acidified Foods)

Responsibilities

Maintain a working knowledge of regulatory and Herbalife guideline requirements.
Resolves day-to-day floor concerns and escalates to management as appropriate.
Contributes and presents quality metrics and defines projects based on data.
Report on Key Performance Indicators (KPIs) and collate data for monitoring targets.
Gather data on performance metrics to facilitate the review of program/ product effectiveness, efficacy, and actions for adherence to quality.
Assign CAPAs to impacted departments. Follow-up on CAPA completion by assisting in implementing corrective or preventative actions (CAPA) to ensure product quality and CAPA Effectiveness
Root Cause Analysis (RCA) and Failure Mode Effect Analysis (FMEA) as a routine.
Review and approve investigations for issues found CAPAs to effectively minimize or eliminate those defects.
Complete preliminary review for Material Review Reports (MRR).
Review and approve Rework Protocols for packaging operations.
Lead/Facilitate Quality Events such as Root Causes Analyses or Kaizen Events.
Support other departments with the completion of RCA and CAPA completion.
Other duties as assigned.