Quality Engineer

Job title:                             Validation Engineer

Department / Division:    Quality Assurance - Validation

Salary Range:                       $86,000 - $111,0000 per year, plus bonus

Location:                            Ada, MI (Hybrid)

*This position must be willing and able to report to the Ada, MI headquarters at least 3 days per week

What we need:

Join our team as a dynamic Validation Engineer, where your passion for the entire lifecycle of consumable products and deep expertise in validation processes, including equipment qualification, process validation, and cleaning/sanitizing, will be crucial. Your role will involve cross-functional collaboration to preemptively solve problems and advocate for early issue resolution across diverse production settings. You will play a key role in integrating new equipment and products, leading validation studies with a focus on efficiency and effectiveness. This opportunity will allow you to apply and enhance your problem-solving skills and technical knowledge in a broad spectrum of quality functions, contributing significantly to our product quality and process improvements.

In this role you will collaboratively or independently provide solutions to a wide range of difficult technical issues.  You will also have the opportunity to learn or use your past experience to execute a broad range of quality functions, including:

• Develop and review validation procedures to ensure sophisticated processes and equipment operate to consistently produce quality products
• Investigate out of specification results encountered during qualification or validation studies.  Work with cross-functional partners to identify and implement corrective actions.
• Interface with manufacturing, process engineering, product development, and regulatory representatives concerning deviations or issues; ensure effective corrective action is implemented as appropriate.
• Participate in quality improvement initiatives and teams or participates as QA lead for cross-functional initiatives including but not limited to equipment qualification, validation, value chain projects and new product launches.
• Represent customer to resolve quality issues encountered during validation studies.
• Ensure that products, materials and services comply with established specifications and technical requirements through application of quality tools and principles.
• Lead and facilitate uniform standards globally - for both product standards and validation best practices
   

Required qualifications:

• Minimum of 3 years of experience in validation, process engineering, plant engineering, manufacturing, and/or Quality Assurance in the CPG, food, or pharmaceutical industry
• Minimum of 2 years of experience specifically focused in one or more of the following areas:
  • Process/packaging validation
  • Cleaning and sanitizing validation
  • Equipment qualification (IQ/OQ/PQ)
• Experience in Global Manufacturing
• Demonstrated experience in Design for Quality or experience in product or process development is preferred
• BS degree in Chemical Engineering, Mechanical Engineering, Packaging Engineering, or a related field.

Preferred Additional Experience:

• Experience in root cause investigations and/or product development
• Experience in or supporting a GMP manufacturing environment  
• Experience with quality standards and Design for Quality practices
• Experience with data analysis, statistical techniques, and problem-solving

Skills to be successful in the role:

• Ability to collaborate with manufacturing, product development, global engineering, and operations engineering to effectively and efficiently resolve issues

This role is "Not" eligible for sponsorship.

What's special about this team:

The Validation team sits within the Nutrition Quality Engineering Department, which is a hardworking team of over 25 engineers across two Amway sites (Ada, Michigan and Buena Park, California).  The team works in a fast-paced environment supporting internal and external manufacturing sites to ensure quality product is produced and supplied to our customers.  Our team works heavily with cross-functional partners such as engineering, product development, planning, suppliers, and manufacturing to prevent and address product quality issues.  Our team also works with our global QA counterparts in over 10 markets across many countries.  There is an ongoing shift from back-end to front-end design for quality work to get ahead of issues and minimize reactive quality work.  

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