Quality Engineer I — CAPA, Audits & Process Improvement

Providien Thermoforming, LLC; San Diego (CA); On-site; USD 75,000 - 97,000; Full time

Job summary

Providien Thermoforming, LLC is seeking a Quality Engineer I to provide quality leadership and technical support to the Value Stream Team on thermoformed products.

Under the Quality Manager, you will plan and coordinate quality tasks, develop inspection plans, review documentation, and drive continual improvement to meet customer and regulatory requirements across medical device, aerospace, and industrial markets.

Qualifications

• Bachelor’s degree in engineering or sciences, or 5+ years of experience working in a technical engineering role.
• Minimum of 3years of experience in manufacturing preferred.
• Experience in Root Cause Analysis investigation (5 Whys, Fishbone, 8D, etc.) is preferred.
• Knowledge of ISO 13485:2016 and other relevant quality standards preferred
• Proven experience in a manufacturing quality control role.
• Background in medical device, aerospace, or plastics/thermoforming manufacturing industries is preferred.

Responsibilities

• 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.

Skills

Root Cause Analysis

CAPA

Quality Leadership

Documentation

Statistical Analysis

Communication

Team Collaboration

Problem Solving

Blueprint Reading

GD&T knowledge

Education

Bachelor’s degree in engineering or sciences

Tools

MS Office

SharePoint

ERP systems

Job description

Providien Thermoforming, LLC is seeking a Quality Engineer I to provide quality leadership and technical support to the Value Stream Team on thermoformed products.

Under the Quality Manager, you will plan and coordinate quality tasks, develop inspection plans, review documentation, and drive continual improvement to meet customer and regulatory requirements across medical device, aerospace, and industrial markets.