Director, Quality & Regulatory Compliance

Mallinckrodt Pharmaceuticals; Madison (WI); On-site; USD 180,000 - 240,000; Full time

Job summary

Keenova seeks a Director of Quality in Madison, WI to establish and maintain quality assurance programs ensuring devices meet applicable regulations and standards. You will lead QA staff, interface with regulators, and drive CAPA processes.

Responsibilities include overseeing QMS, ensuring 510(k)/PMA readiness, and collaborating with R&D, CMOs, and operations to meet product quality and regulatory requirements.

Qualifications

• Experience leading QA teams in medical devices/pharma.
• Hands-on auditing experience and vendor management.
• Familiarity with QSR, CFR, and ISO requirements.

Responsibilities

• Lead site Quality Management System to meet QSR and ISO standards.
• Direct QA staff and consultants; manage corrective and preventive actions.
• Ensure readiness of 510(k) and PMA submissions from QA perspective.
• Represent QA on project teams for design transfer and change control.

Skills

Cross-functional teamwork

Regulatory inspections readiness

Quality leadership

Vendor management

Education

Bachelor's degree

Tools

Microsoft Office

Job description

Keenova seeks a Director of Quality in Madison, WI to establish and maintain quality assurance programs ensuring devices meet applicable regulations and standards. You will lead QA staff, interface with regulators, and drive CAPA processes.

Responsibilities include overseeing QMS, ensuring 510(k)/PMA readiness, and collaborating with R&D, CMOs, and operations to meet product quality and regulatory requirements.