Immediate Interview -QARA

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.
• CAPA analysis/closure, Change Management & QA activities.

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.
• Perform gap assessments of QMS and create forms aligned with requirements.

Job description

Job Description

• Support R&D, Manufacturing Department to ensure compliance with quality system policies and procedures, FDA and international requirements, and ISO Standards for Medical Devices

DUTIES & RESPONSIBILITIES

• Experience in setting up Quality Management system and understand ISO 13485/14971/IEC 62304 / QSR requirements.
• Support documentation for CAPA analysis / Closure, Change Management & related QA activities.
• Ability to Perform Gap Assessment of QMS / Includes forms with respect to the following requirements.