Quality Engineer III

Overview

Uses engineering principles, team facilitation skills, training skill sets, and statistical process control tools to measure and improve key processes integral to the manufacturing of laminated packaging materials for the food, pharmaceutical, and medical industries. Identifies key processes and develops relevant metrics to ensure process variables are quantified and within control. Identifies and conducts projects and facilitates cross functional improvement teams and training to improve manufacturing efficiency and reduce variability.

Focus will be Customer Complaints responses. This will include investigation, implementation of Corrective Action/Preventive Action (CAPA), and Verification of Effectiveness activities.

Bachelor's degree in chemical engineering, Mechanical Engineering, Packaging Engineering, and / or other Manufacturing Engineering Technology related programs with a minimum of 3 years technical experience. Lamination experience and/or 5 years plastic processing background.

• Demonstrated capability to lead cross functional work teams in the implementation of process improvements that yield bottom line results.
• Experience in the implementation of statistical process control and/or lean manufacturing principles within a fast-paced manufacturing environment.
• Engineering/Manufacturing Procedure writing and auditing experience
• Capable of learning and complying with FDA/GMP regulations and ISO 15378 Audits.
• Experience in the implementation of Statistical Process Control within a manufacturing environment.
• Lean, Six Sigma, 8D, Zero Defect, Kaizen, Kan Ban, Single Minute Exchange Die [SMED] background
• High volume manufacturing experience.

• Language
  
  Skills:
  
  Good English communication skills, both verbal and written

• Must have strong attention to detail for analyzing data and making recommendations for improvement.
• Must have strong written and verbal communication skills to effectively communicate across all levels of the organization and with external customers, vendors, etc.
• Ability to compile, write and deliver training to associates on new/revised quality standards and activities.
• Ability to work independently and in a team environment to complete projects.
• Ability to multitask with multiple projects.

• Creativity and Innovation
• Learning and Adaptability
• Problem Solving and Decision Making
• Relationships

• Must be able to support manufacturing operations active 24/7.
• Occasional travel to customers/suppliers may be required.

Voice of the customer: primary contact with the customer on existing product performance not only limited when there are quality issues. Able to translate and evaluate customer quality requests in internal improvement actions needed during production. (i.e.. extra sampling, tighter limits)

• Quality Investigations (8D, CAPA, etc.)
• Assist during quality trials or customer complaint analysis at customer/supplier premises
• Ensures Quality products and processes are maintained by:
  • Understanding and supporting both quality policies and the Quality System.
  • Ensuring quality of products in order to meet or exceed internal and external customer specifications.
  • Identifying and correcting, if possible, any identified quality issues both in the department and plant as a whole.
  • Developing standard targets on all manufacturing lines, translating customer specifications into internal acceptance specifications.
• Actively participates in the continuous improvement process (CI) by:
  • Identifying and addressing any opportunities to reduce internal rejections, cost, improve product/process and/or improve overall operations
  • Participating in CI teams to eliminate problems, streamline operations or other areas as defined by management
  • Participating in CI training and exercises designed to expand the potential for continuous improvement.
• Manage the customer complaint system with the goals of prevention of future occurrences and complaint avoidance utilizing the Root Cause and Correct Action (RCCA) process.
• As part of CAPA implementation: plan, execute, and oversee inspection and testing of products to verify conformance with specifications and deliverables to ensure that all product shipped meets customer requirements in accordance with Customer Specifications.
• Manage substandard/nonconforming materials to the established Site standard operating procedures to ensure that they are controlled within the manufacturing processes and dispositioned appropriately.
• Create, promote and execute quality standards, inspection processes, test methodology, quality plans, documents, reports, etc. to verify conformance with specifications and deliverables.
• Review Material specifications to ensure the necessary criteria and provisions are included to meet the quality and continuous improvement requirements.
• Participate in internal and external quality audits.
• Interface with supplier and customer quality…