Quality Engineer, Medical Devices — QMS & CAPA Lead

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

Benefits offered by this job

Competitive compensation

Generous paid time off

Job summary

Trelleborg Medical Solutions in California is seeking a Quality Engineer to support the development, implementation, and maintenance of a Quality Management System compliant with FDA regulations and ISO standards. You will collaborate with cross-functional teams to ensure product quality and regulatory compliance throughout the lifecycle.

Responsibilities include supporting internal audits, CAPA investigations, and continuous quality improvement using lean principles and Six Sigma tools, with a

Qualifications

• 4 year degree in quality, engineering or related field.
• 2+ years manufacturing experience in a technical support role.
• ASQ Certified Quality Engineer (desired).
• ISO 13485 experience (desired).

Responsibilities

• Develop and maintain Quality Management System per FDA and ISO.
• Lead internal audits and supplier quality activities.
• Drive CAPA investigations and corrective actions.
• Improve manufacturing, inspection, testing, and labeling processes.
• Support cross-functional teams to ensure product quality.

Skills

Quality engineering

Regulatory compliance

Lean manufacturing

CAPA analysis

Root cause analysis

Statistical methods

Microsoft Office

Project management

Education

4 year degree in quality or engineering

Tools

JMP

Microsoft Project

Excel

Access

Job description

Trelleborg Medical Solutions in California is seeking a Quality Engineer to support the development, implementation, and maintenance of a Quality Management System compliant with FDA regulations and ISO standards. You will collaborate with cross-functional teams to ensure product quality and regulatory compliance throughout the lifecycle.

Responsibilities include supporting internal audits, CAPA investigations, and continuous quality improvement using lean principles and Six Sigma tools, with a