Quality Systems Specialist

Title: Prin Quality Systems Spec - Exempt
Location: Onsite 40/hrs week (Mon - Wed)
Address: Minneapolis, MN 55432
Duration: 9+ months with possible extension

HM's Top Needs:

1. Strong understanding of global regulatory requirements for medical devices, including FDA Quality Management System Regulation (QMSR), ISO 13485, and European Medical Device Regulation.

2. Strong understanding of quality systems, including CAPA, change control, training, and management review

3. Familiarity with risk management and root cause analysis tools

• Support key Quality System processes, including Quality System Change Orders, training, CAPAs, issue escalation, internal and external audits, and data analysis.
• Support the end-to-end CAPA process, including initiation, root cause analysis, action planning, implementation tracking, verification, and closure, to ensure timely and effective resolution of quality issues in compliance with internal procedures and regulatory requirements.
• Review and approve training plans associated with change orders to ensure training requirements are appropriately defined, documented, and completed.
• Support continuous improvement activities by helping to implement improvements to strengthen quality system effectiveness and efficiency.
• Support key organizational initiatives and cross-functional priorities as needed.

Education Required: Bachelors

Years’ Experience Required: 7 years