Alltrista - Engineer, Quality

Human Resources • Greer, SC

4d

About The Position

The Quality Engineer is responsible for GMP, ISO, and FDA compliance, as applicable, during project management and transition to manufacturing. The role ensures that customer specifications and inspection methods are understood and followed throughout engineering projects and production, and audits the quality system.

The position works with customers and the Quality Manager on product and inspection requirements for new and customer-supplied mold projects. It develops and executes process validations, inspection and calibration plans, supports quality systems and continuous improvement, and conducts inspections and audits to verify regulatory and customer-specific compliance.

Requirements

• Three to five years of in-process, final, or raw-materials inspection experience in a high-volume production environment.
• Three to five years of experience with SPC, sampling, auditing, blueprint reading, dimensioning, and tolerancing.
• Practical, direct experience using continuous-improvement and quality tools, including control charts, capability studies, DOE, regression analysis, histograms, and fishbone charts.
• Practical, direct experience with computer hardware and software, including LAN/CIM and statistical, graphical spreadsheet, and word-processing software.
• Background in corrective action, root cause analysis, preventive action, and continual improvement.
• Knowledge of ISO 9001-based Quality Management Systems (QMS).
• Knowledge of ISO 13485 Medical Devices.

Nice To Haves

• Associate or bachelor's degree preferred.

Responsibilities

• Work with customers and the Quality Manager to understand and communicate product and inspection requirements for new and customer-supplied mold projects.
• Develop and execute product and equipment process validation procedures, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for new and customer-supplied molds.
• Coordinate, develop, and write product and custom equipment inspection and calibration plans for new and customer-supplied molds.
• Help establish and implement quality systems, internal auditing, supplier approval, tooling and facility preventive maintenance programs, calibration, training, and CAPA programs.
• Evaluate product from design of experiments (DOE) activities to prepare for and support parametric release and quality assurance.
• Perform and document First Article/Protocol inspections for new, customer-supplied, and modified molds.
• Use SPC software to collect and evaluate process data for continual improvement.
• Conduct routine audits, evaluations, and analyses of manufacturing, engineering, tooling, and warehousing activities to assess FDA or customer-specific regulatory compliance.
• Maintain knowledge of current inspection and testing instrumentation and techniques and integrate them into existing methods and programs.

What This Job Offers

• Job Type: Full-time
• Education Level: No Education Listed