- Develop and Review Validation Procedures: Create and review protocols to ensure consistent high-quality outcomes from complex systems and machinery.
- Investigate Specification Deviations: Address anomalies discovered during qualification or validation by working with interdisciplinary teams to identify and rectify root causes.
- Cross-Functional Interface: Collaborate with various departments to address discrepancies and implement effective remedial actions.
- Quality Improvement Participation: Lead quality enhancement projects and initiatives, overseeing equipment certification, process validation, supply chain improvements, and product launches.
- Customer Representation: Advocate for customers in resolving quality concerns related to validation processes.
- Compliance Assurance: Ensure products and services adhere to specified standards by utilizing quality management tools.
- Global Standards Leadership: Drive the establishment and alignment of global standards for product specifications and validation methodologies.
- Minimum of 3 years of experience in validation, process engineering, plant engineering, manufacturing, and/or Quality Assurance in the CPG, food, or pharmaceutical industry
- Experience working directly with products
- Global QA compliance / GMP experience
- Experience in root cause investigations
- 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.
- 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 or supporting a GMP manufacturing environment
- Understanding of quality standards and Design for Quality practices
- Proficiency in data analysis, statistical techniques, and problem-solving
- Ability to collaborate with various departments to effectively resolve issues
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Quality Engineer - Ada, United States - Amway
Description
Job title: Quality Engineer
Department / Division: Quality Assurance/Innovation and Sciences
Salary Grade: EXB 15
Salary Range: $86k to $111k/year, plus Bonus
Location: Ada, MI
About the Job:
We are in search of a motivated engineer intrigued by the opportunity to play a vital role in the development of consumable products. Our ideal candidate possesses a deep knowledge of equipment qualification, process validation, and cleaning/sanitizing validation. Collaboration, problem-solving, and proactive issue resolution are key attributes we are looking for in individuals interested in joining our team. This position holds significant responsibilities spanning various production areas and equipment types, making it pivotal to our operations.
Your collaborative nature and problem-solving skills will be highly valued in this role as you engage with internal and external partners. Employing a wide range of validation practices and principles will be essential as you ensure that studies are meticulously designed and executed. This position offers you the exciting opportunity to lead or participate in cross-functional initiatives aimed at enhancing product quality and processes, fostering your professional advancement.
Initially, your focus will be on supporting the integration of new equipment and products. Rest assured, you will have the support and guidance of our experienced team while you author and oversee qualification studies, process validation, and cleaning/sanitizing validation studies. Your expertise in these areas will drive the implementation of best practices and calculated risks to ensure efficient and effective studies.
In this role, you will tackle a variety of complex technical challenges either collaboratively or independently. You will also have the chance to leverage your past experiences to contribute to a wide range of quality functions, including:
Required qualifications:
Relevant Experience:
Skills for Success:
This position does not offer sponsorship opportunities.
Why Join Us:
Join our dynamic Nutrition Quality Engineering Department, a team of over 25 engineers spread across Amway sites in Ada, Michigan and Buena Park, California. We operate in a fast-paced environment supporting both internal and external manufacturing sites to consistently deliver quality products to our customers. Collaboration with engineering, product development, planning, suppliers, and manufacturing is key to anticipate and address product quality issues effectively. Additionally, we work closely with our global QA counterparts in over 10 markets worldwide, focusing on proactive quality measures to minimize reactive quality work.
Note: Actual compensation packages are determined based on various factors unique to each candidate, such as skill set, experience level, certifications, and office location. Variations may occur in different locations due to labor cost considerations.
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