Quality Engineer – Medical Solutions (Lean & CAPA)

Trelleborg Sealing Solutions; Paso Robles (CA); On-site; USD 90,000 - 115,000; Full time

Job summary

Trelleborg Medical Solutions is seeking a Quality Engineer to support the development, implementation, and maintenance of a Quality Management System compliant with FDA regulations and ISO standards. This role partners with cross-functional teams, customers, and suppliers to ensure product quality and regulatory compliance.

The role emphasizes Lean manufacturing, CAPA, NC/MRB management, and continuous improvement to enhance manufacturing, inspection and labeling processes while ensuring

Qualifications

• 4 year degree in quality, engineering or related field.
• 2+ years in a manufacturing environment in a technical support role.
• ASQ Certified Quality Engineer (preferred).
• Formal Six Sigma Yellow/Green belt training (preferred).
• Experience with ISO 13485 (preferred).

Responsibilities

• Supports internal audit program and regulatory compliance.
• Drives quality initiatives for new and existing products and CAPA workflows.
• Maintains Non-Conforming (NC) and MRB processes and trends.
• Performs data analysis and supports design for manufacturability and process improvements.

Skills

Quality Engineering

Lean Manufacturing

CAPA

ISO 13485

Statistical Analysis

Education

Bachelor's degree in quality/engineering or related field

Tools

Microsoft Project

Microsoft Access

JMP

Microsoft Excel

Job description

Trelleborg Medical Solutions is seeking a Quality Engineer to support the development, implementation, and maintenance of a Quality Management System compliant with FDA regulations and ISO standards. This role partners with cross-functional teams, customers, and suppliers to ensure product quality and regulatory compliance.

The role emphasizes Lean manufacturing, CAPA, NC/MRB management, and continuous improvement to enhance manufacturing, inspection and labeling processes while ensuring