Quality Engineer III

TekniPlex•Winston Salem, NC

About The Position

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.

Requirements

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 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.
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.
Frequent exposure to typical hazards found in a manufacturing environment, including walking/standing for long periods of time, bending and proximity to high-speed machinery.

Responsibilities

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 representatives concerning problems with quality assurance of specific items and ensure that effective corrective actions are implemented as necessary while maintaining strong positive working relationships with customers and suppliers.
Drives continuous improvement activities and stays current with the industry best practices.
Work directly with machine operators to identify needs and develop solutions; work with Maintenance on equipment modifications and preventative /predictive maintenance to ensure reliability.
Assess and make improvement recommendations through the monitoring of equipment performance.
Identify, propose and execute projects to improve customer satisfaction, through performance and product reliability.
Develop / improve product reliability, performance consistency and cost effectiveness to support the company’s continuous improvement processes.
Statistically evaluate process parameters and assess impacts of material changes to efficiency and process integrity, which will result in scrap rate reductions and increase yields.
Evaluate and update risk assessment tools, such as FMEA/control plans, based on current performance and customer complaint feedback.
Report to management on quality issues, trends and recommendations through accurate reports as necessary.
Maintain and protect proprietary information as related to Company and its customers.
Implement corrective actions to improve quality, using lean manufacturing and/or Six Sigma principles.
Facilitates cross functional improvement teams with the objective of implementing lean manufacturing principles.
Develop thorough knowledge of all manufacturing processes and equipment; monitor and assess all equipment performance; develop requirements and participate in CER development for new/modified equipment with the goal to ensure and improve quality and reduce internal scraps and/or returns.
Develop strategies for process improvement and evaluate impact of such changes; actively participate in and/or drive root cause analysis and process improvement efforts.
Be the plant liaison for trials and participate in all associated meetings and activities to ensure success, cross functional with Engineering and R&D group.
Perform other duties as assigned.