Engineer I, Quality Assurance

THE ROLE: 

 

The Quality Assurance Engineer I will be part of the Quality group at Herbalife Innovation & Manufacturing, HIMLF. This individual will be responsible for resolving day to day floor concerns and escalate to management, report on KPIs and contribute / present quality metrics during Management review. Perform root cause analyses and lead CAPAs for Quality Problem Reports, Material Reviews, Product Complaints, and Non-Conforming products. 

 

 

WHAT’S SPECIAL ABOUT THE TEAM: 

 

The Quality Engineering team falls under the Quality Assurance umbrella. This team will be working together in a collaborative and flexible manner with various departments towards a common goal of producing safe and quality products. Brainstorming, joint projects, and collaboration are all common elements of our team environment. Strong, open communication is essential for success.

 

 

HOW YOU WOULD CONTRIBUTE: 

 

• 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 during Management Review.

• 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.

• Report Root Cause Failure Analysis (RCFA) findings to management, including on-going

corrective/preventive actions, and the effectiveness of those actions put into practice.

• Review and approve Non-conformance Material Report (NMR) investigations for issues found at the

distribution centers.

• 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 continuous improvement projects and CAPA completion.

• Other duties as assigned

 

 

SUPERVISORY RESPONSIBILITIES: 

• none

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Skills

• Knowledge of Good Manufacturing Practices (GMP), Food and Drug Administration (FDA) regulations (FDA 21 CFR – Part 111,114 and 117) and GMP documentation procedures. 
• Excellent written and verbal communication skills.
• Must be capable of organizing data from multiple sources, extracting key information and documenting investigation detail
• Proficient use of MS Office, including Word and Excel 
• Strong investigative skills
• Ability to facilitate and lead group discussions.
• Self-motivated and able to work collaboratively in a team-based environment.
• Understands the importance of group thought, information sharing, and collaboration.
• Must demonstrate initiative and a willingness to learn.
• Must be capable of organizing data from multiple sources, extracting key information and documenting investigation detail.
• Ability to organize workload, prioritize responsibilities, meet deadlines and multi-task on several projects individually as well as in a team environment.

 

Experience: 

 

• 3-5 years experience in a quality/regulatory environment 
• Working Knowledge of basic GMP and QA/QC in the food, nutraceutical or pharmaceutical industry

 

Education: 

• BA/BS degree in a scientific field; additional 4 years of relevant experience may be considered in lieu of degree

 

 

PREFERRED QUALIFICATIONS

• Previous experience working in a food or dietary supplement manufacturing plant Quality Assurance setting
• ASQ Quality Engineering, Six Sigma, or applicable certifications
• Experience with Oracle and Agile
• PCQI Certified
• Experience using data analysis computer tools and statistical analysis
• Two years Quality Engineering experience in a regulated GMP environment
• BS or MS degree in Quality Engineering

 

 

• Heavy office work, some lifting, considerable walking, some climbing around machinery.
• 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

 

 

 

 

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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.