Quality Systems and Regulatory Compliance Manager

Job Description

Job Description

Step into the role

Picture your morning: you scan overnight production data, spot a trend, and huddle with inspectors to fine-tune the inspection plan. By midday, you brief senior leadership on Quality Management System (QMS) performance and prioritize improvement actions. In the afternoon, you mentor a Quality Engineer through a Corrective Action Request (CAR), kick off a training refresh, and verify we’re fully aligned to the latest ISO 9001 and ISO 13485 requirements. That’s a day in the life of our Quality Systems and Regulatory Compliance Manager—driving excellence across a fast-paced manufacturing operation.

What you’ll lead

• Own the development, implementation, maintenance, and continual improvement of our QMS across manufacturing.
• Report to senior management on QMS performance, risks, and targeted improvements.
• Promote regulatory awareness and customer requirements throughout the organization.
• Shape a quality-first culture where every team member contributes to process improvement and company goals.

Operational impact

• Design, deploy, and validate an effective training program that proves its impact.
• Lead the internal audit program and oversee NMR, CAR, PAR processes, plus the Continuous Improvement Program.
• Implement and sustain inspection methods that detect and prevent defects.
• Mentor, train, motivate, and lead a team of Inspection personnel and Quality Engineer(s).
• Partner cross-functionally and take on additional assignments from the Director of Operations or CEO as needed.
• Ensure ongoing compliance with the most current ISO 9001 and ISO 13485 standards.

What success looks like

• Quality objectives defined in the QMS are consistently met—and exceeded—year after year.
• Your team performs at a high level, confidently executing with or without your direct presence.

Qualifications

• 2–5 years in a quality or inspection role.
• Hands-on experience with ISO 9001 and/or ISO 13485.
• Manufacturing environment background and people-management experience preferred.