Quality Engineer

Summary:

An opportunity is available for an experienced Quality Engineer to support quality systems, investigations, compliance, and continuous improvement within a regulated medical-device manufacturing environment.

Roles & Responsibilities:

Manage and investigate nonconforming materials, products and processes

Support the complete CAPA lifecycle, including investigation, documentation and effectiveness activities

Conduct structured Root Cause Analysis (RCA) and problem-solving

Maintain compliance with established Quality Management System requirements

Support compliance with ISO 13485 and FDA 21 CFR Part 820 / QMSR requirements

Identify and implement quality and manufacturing process improvements

Apply Lean Manufacturing and Six Sigma methodologies to reduce defects and improve operational performance

Support inspection-ready documentation and quality records

Collaborate with manufacturing, engineering and other cross-functional teams to resolve quality issues

Qualification:

Medical-device industry experience is mandatory

CAPA and Nonconformance Management experience

Quality investigations and Root Cause Analysis

Strong Quality Management Systems knowledge

ISO 13485 experience

FDA QMSR / 21 CFR Part 820 knowledge

Continuous improvement and process-improvement experience

Lean Manufacturing / Six Sigma knowledge

Experience working within highly regulated manufacturing environments