Quality Systems Specialist I

Forj Medical • Saint Paul, MN

22h

About The Position

Quality Systems Specialist I is responsible for maintenance and improvement of the core Quality Management System (QMS) processes (CAPA, Internal Audit, External Audit, and QMS SOPs, as specific job duties are assigned) to ensure compliance to 21 CFR Part 820, ISO 13485 and other applicable national and international regulations and standards. This role will be directly responsible for supporting customer audits, internal audits, CAPA (Corrective and Preventive Action) system and QMS procedures.

Requirements

• Bachelor’s or Associates degree with 0+ years of experience in the following disciplines: –or–3+ years of equivalent industry experience in the following processes:
• Direct customer service and communication interaction (written & verbal)
• Quality Assurance, Control, or Systems
• FDA or ISO regulated medical device manufacturing
• CAPA system administration or direct experience.
• Participation in audits of processes or systems.
• Experience in using and applying analytical tools to decision making.
• Ability to work independently and in a team environment.
• High proficiency in use of standard electronic business tools: Outlook, Word, PowerPoint, Excel, OneNote, Visio, Teams
• Effective communication skills of technical issues, ability to make data driven decisions, passionate for change and continuous improvement, and embodying a strong sense of urgency.

Nice To Haves

• Professional training/certification in auditing
• Professional training/certification in root cause analysis
• Professional training/certification in CAPA/Investigations

Responsibilities

• Execution and management of internal audit program to ensure compliance.
• Support of external audits with customer, regulatory bodies and product inspections, as assigned.
• Execution and management of the CAPA process to ensure it is timely, compliant, and effective.
• Review and support of QMS procedures to ensure compliance to 21 CFR Part 820, ISO 13485 and other applicable national and international regulations and standards throughout the full scope of the Quality Management System.
• Administration and support of corporate standards library.
• Data collection and cursory analysis of core Quality Management System Processes, to support compliance-based decision making and assess the effectiveness of the QMS.
• Support of the Standards Library.
• Support of Learning Management System (LMS) for quiz creation and administration to ensure training to QMS documentation is assigned and is compliant to internal training procedure.
• Assist with other technical tasks as requested or assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree