Job Details
Skills And Tools:
Job Description
The person hired for the position of Quality Engineer will be responsible for implementing quality improvements to a wide range of processes and products. The person will actively be involved in all quality systems related functions and assist in the handling of audit preparations and execution at the manufacturing plant. The person will directly interface with the customer in handling critical issues, complaint investigations and in driving projects and improvement plans related to the projects they purchase. In addition, the person will interface with the manufacturing areas on a variety of quality improvement activities and will report to the Plant Manager.
Primary Responsibilities include but are not limited to the following:
- Lead and execute quality improvement projects
- Investigate customer complaints with root cause analysis, and initiate follow-up improvements and control plans to prevent recurrence
- Develop and maintain product workmanship standards and sampling plans for each product line
- Lead internal audits and assist in maintaining the plant’s internal quality management system to the requirements of International Organization for Standardization (ISO) 9001:2015
- Maintain Product Specifications and issue product Certificates of Conformance/Analysis to customers as needed
- Learn Quality Control (QC) Lab test methodologies and gain an understanding how each instrument works to support daily lab activities
- Conduct process capability studies and perform measurement system analysis on test equipment and new test methods
- Participate in daily Lean Manufacturing improvement efforts
- Support Manufacturing Teams with Management of Change (MOC) projects to further align and grow the quality culture
- Support the Development Team with the execution of qualification plans, QC test method development and transition of quality test into manufacturing as part of the New Product Introductions (NPI) process.
- Establish and cultivate a network of resources (laboratory, manufacturing, engineering, sales and marketing) to facilitate completion of assignments
Job Requirements
Basic Qualifications:
- Bachelor's degree or higher in a Science, Technology, Engineering and/or Mathematics (STEM) discipline from an accredited university
- Minimum of three (3) years of combined quality, manufacturing and/or continuous improvement experience in a private, public, government or military environment
- Experience working with customers or key accounts
Preferred Qualifications:
- Experience with Lean Six Sigma and/or Green Belt certified
- Experience using statistical software packages (e.g. Minitab®) to analyze data
- Experience in the areas of ISO 9001:2015, ISO 13485 and/or cGMP compliance requirements for the Food or Medical Device Applications
- Quality Engineering experience in an assembly or manufacturing environment with proven project management skills
- Professional certification, such as Certified Quality Engineer (CQE) through American Society for Quality (ASQ)
- Recognition and certification as a trained internal auditor or lead auditor
- Experience implementing Statistical Process Control (SPC) and Run to Target methodologies for industrial manufacturing processes
- Excellent communication skills (oral, written and presentation)
- Microsoft Office proficient
