Quality Engineer (Nutrition)

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

 

What do we need:

 

We are seeking a driven, ambitious engineer who is interested in playing a crucial role across the life cycle of consumable products.  We are seeking team members who have a deep understanding of equipment qualification, process validation, and/or cleaning/sanitizing validation.  Our team is looking for someone who can collaborate across multiple functions, problem-solve, and advocate for the resolution of issues early.  This position will have a significant responsibility across a range of production areas and equipment types, making it a key part of our operations.

 

Your ability to work collaboratively and problem-solve will be valued in this role as you work broadly with many internal and external partners.  You will use a broad application of validation practices and principles to ensure studies are designed and executed with quality in mind.  You will have the exciting opportunity to manage, lead, and/or participate in complex cross-functional efforts to improve product quality or processes, providing a platform for your professional growth and development.

 

Your initial focus will be supporting the influx of new equipment and new products. Rest assured, you will not be alone in this endeavor. You will be authoring and overseeing equipment qualification, process validation, and cleaning/sanitizing validation studies, with the support and guidance of our experienced team.  Your expertise in these areas will drive best practices and appropriate risk-taking to ensure efficient and effective studies.

 

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: Craft and scrutinize protocols to guarantee that complex systems and machinery consistently yield high-quality outputs.
• Investigate Specification Deviations: Examine anomalies found during qualification or validation. Collaborate with interdisciplinary teams to pinpoint and rectify the root causes.
• Cross-Functional Interface: Liaise with manufacturing, engineering, development, and regulatory bodies regarding discrepancies; ensure the deployment of effective remedial measures.
• Quality Improvement Participation: Engage in quality enhancement projects, serving as the Quality Assurance (QA) leader for cross-departmental endeavors, including equipment certification, process validation, supply chain enhancements, and product introductions.
• Customer Representation: Act on behalf of customers to address and resolve quality concerns arising from validation processes.
• Compliance Assurance: Verify that all products, materials, and services meet the prescribed standards and technical criteria by employing quality management tools and methodologies.
• Global Standards Leadership: Spearhead the establishment and harmonization of global standards, encompassing both product specifications and validation methodologies.

 

 

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
• 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.

 

Experience that would be helpful to have:

• 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)

 

Skills to be successful in the role:

• 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
• 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.

 

 

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