Quality Systems & Compliance - Medical Devices (ISO)

Deegit Inc; Mounds View (MN); On-site; USD 65,000 - 90,000; Full time

Job summary

A medical device company based in Mounds View seeks a professional to support R&D and Manufacturing Departments in compliance with quality policies, FDA and international standards, and ISO requirements. The role involves setting up a Quality Management system, performing Gap Assessments, and managing documentation for CAPA analysis and Change Management. Strong understanding of ISO 13485 and related standards is required.

Qualifications

• Experience in setting up Quality Management system and understanding of ISO 13485/14971/IEC 62304 / QSR requirements.
• Ability to conduct Gap Assessment of QMS.

Responsibilities

• Support R&D and Manufacturing Department to ensure compliance with quality system policies and procedures.
• Support documentation for CAPA analysis, Closure, Change Management & related QA activities.

Job description

A medical device company based in Mounds View seeks a professional to support R&D and Manufacturing Departments in compliance with quality policies, FDA and international standards, and ISO requirements. The role involves setting up a Quality Management system, performing Gap Assessments, and managing documentation for CAPA analysis and Change Management. Strong understanding of ISO 13485 and related standards is required.