The quality manager will oversee and maintain our Quality Management System (QMS) in a regulated environment. In this role, they will be responsible for ensuring compliance with key industry standards, including ISO and FDA regulations, while managing quality control processes and driving continuous improvement initiatives. They will lead corrective and preventive actions (CAPA), conduct risk assessments, and collaborate with cross-functional teams to ensure product safety, efficacy, and regulatory compliance.

This is an onsite position in St. Paul MN.

Qualifications and Experience:

• Strong technical writing background
• Technical expert in regulations for med device and pharma
• Experience writing Comprehensive reports
• Experience of or familiarity moving paper based QA into electronic
• People management experience
• 5 + years medical device/pharmaceutical experience in a manufacturing environment.
• Minimum 5 years experience in Quality Assurance Operations Management; 2 years in Manufacturing Operations
• FDA (CFR 820, 210 and 211), and ISO 13485 systems experience.