Quality System Manager

Quality Manager

Location : Oak Creek, Wisconsin

Standard business hours, Monday–Friday.

Position Overview

The Quality Manager will play a critical leadership role in establishing and maintaining the Quality Management System (QMS) for a new state-of-the-art medical manufacturing facility in Oak Creek, Wisconsin. This position is responsible for building the quality function from the ground up—ensuring all processes, systems, and personnel are aligned with FDA, ISO 13485, MDSAP, and MDR regulatory standards.

The ideal candidate is a hands-on, strategic quality leader with a strong background in medical device manufacturing and 3D printing technologies, capable of fostering a culture of quality and continuous improvement within a growing organization. This is a full-time, on-site role with no travel required.

Key Responsibilities

Quality Management System (QMS) Development & Oversight

• Establish, implement, and maintain a comprehensive Quality Management System in alignment with ISO 13485, FDA 21 CFR Part 820, MDSAP, and MDR requirements.
• Ensure compliance with all applicable medical device regulatory standards and customer requirements.
• Develop and document quality processes, policies, and standard operating procedures (SOPs) to support production startup and scale-up.
• Lead the site's efforts to obtain and maintain relevant quality certifications and regulatory approvals.

Product Quality & Compliance

Leadership & Team Management

Customer Feedback & Continuous Improvement

Audits & Management Reviews

Qualifications

No travel required.

Reports To : Plant Manager

Direct Reports : 6–7