Quality Engineer

Summary

The Quality Engineer I provides quality leadership and technical support to their Value Stream Team and quality technicians within Providien Thermoforming’s manufacturing operations. Working under the guidance of the Quality Manager, this role plans, initiates, coordinates, and evaluates activities related to the application, development, and maintenance of quality tasks, processes, and systems for thermoformed products. The primary responsibility of this role is to ensure that thermoformed components and assemblies meet required quality standards, customer expectations, and applicable regulatory requirements across our medical device, aerospace, and industrial markets.

Essential Job Functions

• Provide daily quality support to manufacturing, Engineering, including inspection, assembly, packaging and shipping operations.
• Investigate nonconforming products, scrap, rework, and customer complaints; identify root cause and implement effective corrective actions.
• Lead or Support CAPAs using tools such as 5 whys, fishbone diagrams, and process data analysis.
• Develop and maintain inspection plans, work instructions, acceptance criteria and manufacturing quality records.
• Review production documentation for completeness, accuracy and compliance with GDP.
• Partner with manufacturing and engineering teams on process changes, validation activities, risk assessment and FAI.
• Use trend data, defects rates, and quality metrics to identify recurring issues and measure improvement.
• Support supplier quality activities, including evaluation of supplier non-conformances and corrective actions.
• Participate in internal, customers and ISO 13485 audits; help prepare responses and close finding on time.
• Train and coach employees on quality requirements and practical application of procedures on the manufacturing floor.
• Develop and implement standards and methods for inspecting, testing, and evaluating thermoformed products and components.
• Develop and deliver quality training materials to increase awareness across the Value Stream Team.
• Review of customer specifications
• Participate in the design and process of FMEAs, Design of Experiments, PPAPs, Process/Product Capability Studies, and Product Liability Meetings.
• Continuously improve quality systems and processes.

Other duties as required in support of the department and the company.

Supervisor Responsibilities

This role does not include supervisory responsibilities over other employees. The Quality Engineer provides functional quality leadership and technical guidance to quality technicians within their assigned Value Stream Team.