Lead Medical Device Quality Engineer (GMP & Regulatory)

Innovize & Xcel Scientific; Saint Paul (MN); On-site; USD 90,000 - 120,000; Full time

Job summary

Innovize & Xcel Scientific, located in Saint Paul, MN, is seeking a Quality Engineer to develop and maintain methodologies that meet customer requirements. This role ensures compliance with U.S. and international regulations regarding quality standards.

The ideal candidate will have over 8 years in medical manufacturing, experience in GMP facilities, and knowledge of quality system standards including ISO, FDA, and MDD. The position is a full-time role focused on enhancing product quality and regulatory adherence.

Qualifications

• Minimum 8 years experience in a medical manufacturing quality environment.
• Direct experience in a Quality role supporting operations in a manufacturing GMP facility.
• Strong background in international Quality System standards.

Responsibilities

• Works to implement effective controls for product manufacturability.
• Leads testing and validation of new customer product designs.
• Creates and maintains Regulatory Affairs product files.

Skills

Quality Engineering

Risk Management

Process Improvement

Root Cause Analysis

Regulatory Compliance

Education

Bachelor's Degree

Quality Engineering Certification

Tools

Microsoft Office

MiniTab

Job description

Innovize & Xcel Scientific, located in Saint Paul, MN, is seeking a Quality Engineer to develop and maintain methodologies that meet customer requirements. This role ensures compliance with U.S. and international regulations regarding quality standards.

The ideal candidate will have over 8 years in medical manufacturing, experience in GMP facilities, and knowledge of quality system standards including ISO, FDA, and MDD. The position is a full-time role focused on enhancing product quality and regulatory adherence.