A healthcare solutions company in St. Paul, MN, seeks a Quality Lead to own its Quality Management System (QMS). You will ensure compliance with ISO standards, support audit readiness, and foster a culture of continuous improvement. Candidates should have a minimum of 3 years of experience in regulated environments and demonstrate expertise in quality systems and documentation control. This role offers competitive compensation and a comprehensive benefits package, including health insurance and paid time off.
Qualifications
Minimum 3 years of experience in a regulated manufacturing environment.
Working knowledge of ISO 9001 and current Good Manufacturing Practices (cGMP).
Experience with NCRs, CAPAs, and document control.
Responsibilities
Own and maintain the Quality Management System (QMS).
Serve as the primary Quality representative across departments.
Lead the QMS training program and maintain training records.
Skills
Quality Management Systems (QMS)
ISO 9001 knowledge
cGMP knowledge
Strong written and verbal communication
Detail-oriented
Proficiency in Microsoft Office
Education
Bachelor’s degree in a related field
Tools
Electronic Quality Management Systems (eQMS)
SharePoint
Job description
A healthcare solutions company in St. Paul, MN, seeks a Quality Lead to own its Quality Management System (QMS). You will ensure compliance with ISO standards, support audit readiness, and foster a culture of continuous improvement. Candidates should have a minimum of 3 years of experience in regulated environments and demonstrate expertise in quality systems and documentation control. This role offers competitive compensation and a comprehensive benefits package, including health insurance and paid time off.