Quality Assurance Engineer I

Overview

THE ROLE

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.

HOW YOU WOULD CONTRIBUTE

• Maintain a working knowledge of regulatory and Herbalife guideline requirements.
• Resolves day-to-day floor concerns and brings up concerns to management as needed.
• 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 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

The Quality Engineering team is a self-directed and highly motivated group that requires minimal oversight and maintain a high level of productivity. 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

Qualifications

SKILLS AND BACKGROUND REQUIRED TO BE SUCCESSFUL

Skills

• 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 track record of being 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.

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.

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 ventilated

Noise levels are considered low to moderate, with some areas requiring hearing protection

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At Herbalife, we value doing what’s right. We are proud to be an equal opportunity employer, making decisions without regard to race, color, religion, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected characteristic. We value diversity, strive for inclusivity, and believe the differences among our teammates is a key contributor to Herbalife’s ongoing success.

Herbalife offers a variety of benefits to eligible employees in the U.S. (limited to the 50 States and the District of Columbia), which includes Group Health Programs, other Voluntary Benefit Programs, and Paid Time Off. Group Health Programs include Medical, Dental, Vision, Health Savings Account (HSA), Flexible Spending Accounts (FSA), Basic Life/AD&D; Short-Term and Long-Term Disability and an Employee Assistance Program (EAP).

Other Voluntary Benefit Programs include a 401(k) plan, Wellness Incentive Program, Employee Stock Purchase Plan (ESPP), Supplemental Life/Critical Illness/Hospitalization/Accident Insurance, and Pet Insurance. Paid time off includes Company-observed U.S. Holidays, Floating Holidays, Vacation, Sick Time, a Volunteer Program, Paid Maternity and Paternity Leave, Bereavement Leave, Personal Leave and time off for voting.

If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please email your request to [email protected].

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