The Quality Assurance Engineer I will be part of the Quality group and will work onsite at our state of art Innovation and Manufacturing facility in Winston-Salem, NC. This is a high visibility role that interacts with Operations to create great working relationships between the two groups. Will be responsible for performing root cause analyses and leading CAPAs for Material Reviews, Product Complaints, and Non-conforming products. Should be proficient in data driven decision making for quality defects and developing quality related projects for drive down those defects.
• Maintain a solid understanding of regulatory and Herbalife guideline requirements.
• Resolves day-to-day floor concerns and raises to management as appropriate.
• Supplies and presents quality metrics and defines projects based on data.
• Report on Key Performance Indicators and collate data for monitoring targets.
• Gather data on performance metrics to facilitate the review of program/ product effectiveness, efficacy, and actions for alignment 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.
WHAT’S SPECIAL ABOUT THE TEAM:
Are you ready to be part of an outstanding Quality team? We are seeking a highly skilled and motivated Quality Assurance Engineer I to join our dynamic group. The team is a self-directed and highly motivated group that requires minimal guidance and maintains a high level of efficiency. They are results driven and proud of the work they accomplish to prevent quality defects yet humble that they tend to stay away from the spotlight. The Team has over 50 years of combined Herbalife knowledge.
SUPERVISORY RESPONSIBILITIES:
none
SKILLS AND BACKGROUND REQUIRED TO BE SUCCESSFUL:
Skills
• Solid understanding of assessment tools and reporting
• Strong Microsoft Excel skills including data analysis (statistics, pivot tables, etc.) Ability to organize data from multiple sources, extracting key information and documenting investigation detail.
• Strong Microsoft Office Suite skills
• Excellent written and communication skills with the ability to facilitate and lead group discussions
• Strong investigative skills
• Knowledge of Good Manufacturing Practices, Food and Drug Administration (FDA) regulations (FDA 21 CFR – Part 111/117) and documentation procedures.
• Proven track record to be self-motivated as well as to work collaboratively in a team-based environment is required.
• Understands the importance of group thought, information sharing, collaboration and appropriate challenges to status quo
• Desire to be involved stay positive and make a difference
• Must demonstrate initiative and a willingness to learn.
Experience:
• 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
Education:
• Bachelor's degree in Life Science, Engineering, or Physical Science
• In lieu of a degree, 7+ years of applicable experience will be considered
PREFERRED QUALIFICATIONS:
• 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)
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.
Moderate: Mostly standing, walking, bending, frequent lifting to Arduous: Heavy lifting, bending, crawling, climbing
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.
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