Sr. Quality Systems Specialist- CAPA & Recall

IMRIS Imaging, Inc DBA IMRIS•Chaska, MN

1d•$110,000 - $115,000•Hybrid

About The Position

As a global leader in intraoperative MRI, IMRIS Imaging, Inc. delivers fully integrated surgical environments that provide clinicians with real-time MRI and imaging insights during procedures. These solutions are designed to improve clinical decision-making, enhance surgical precision, and ultimately drive better patient outcomes. The IMRIS Surgical Theatre enables seamless intraoperative imaging directly within the operating room, eliminating the need to move patients and ensuring timely access to critical data when it matters most. To date, more than 70,000 patients have benefited from procedures performed in IMRIS Surgical Theatres worldwide, supporting improved resection rates, reduced reoperation needs, and extended life expectancy in complex neurosurgical cases. IMRIS continues to advance the field by integrating next-generation intraoperative imaging technologies and shaping the future of neurosurgery and image-guided interventions across leading hospitals globally. We are currently searching for a Sr. Quality Systems Specialist- CAPA & Recall to join our team. This hybrid role is required to be on-site at our Chaska, MN headquarters three days a week. Please note: There is no relocation offered for this role. The ideal candidate will currently reside in the Greater Twin Cities metropolitan area.

Requirements

Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or related technical discipline preferred.
Equivalent combination of education and relevant experience may be considered.
Minimum 5 to 8 years of experience in Quality Assurance, Quality Systems, Regulatory Affairs, or related roles within the medical device industry or other regulated industry.
Experience managing CAPAs, nonconformances, recalls, advisory notices, field actions, complaints, or quality system processes preferred.
Experience participating in regulatory inspections and quality audits preferred.
Working knowledge of CAPA methodologies, root cause analysis tools, and effectiveness verification techniques.
Strong understanding of Quality Management System requirements.
Knowledge of: FDA 21 CFR Part 820, ISO 13485, MDSAP, EU MDR, Canadian Medical Device Regulations, Other applicable global medical device regulations
Strong organizational and project management skills.
Excellent written and verbal communication skills.
Ability to manage multiple projects and priorities simultaneously.
Strong analytical and problem-solving skills.
Ability to effectively collaborate with cross-functional teams.
Proficiency in Microsoft Office applications and quality management software systems.
Ability to interpret procedures, regulations, technical documentation, and quality records.

Responsibilities

Manage day-to-day administration of the CAPA process.
Coordinate CAPA activities from initiation through closure.
Lead CAPA review meetings and track action item completion.
Work with process owners and subject matter experts to develop investigations, root cause analyses, corrective actions, and preventive actions.
Review CAPA records for completeness, accuracy, and compliance with quality system requirements.
Track due dates and escalate overdue actions as appropriate.
Ensure verification of effectiveness activities are completed and documented.
Develop and maintain CAPA metrics and trend analysis reports, provide data for Quality Management Reviews.
Identify opportunities for quality system and process improvement through CAPA data analysis.
Coordinate product recalls, advisory notices, field actions, and other post-market actions in accordance with company procedures and regulatory requirements.
Maintain recall, advisory notice, and field action records.
Initiate, process and drive to completion all Health Hazard Evaluation related activities.
Organize and lead the Device Safety Review Board.
Assist in development of recall strategies, risk assessments, customer notifications, and effectiveness checks.
Track field action progress and ensure completion of required activities.
Support regulatory reporting and documentation associated with recalls and advisory notices.
Prepare status reports and metrics related to recalls and field actions, provide data for Quality Management Reviews.
Ensure all activities are executed in accordance with established quality procedures and regulatory requirements.
Identify and conduct continuous improvement initiatives throughout the Quality Management System.
Support training activities related to CAPA, recalls, advisory notices, and other quality system processes.
Provide front-room support and records for internal audits, external audits, MDSAP audits, and regulatory inspections.
Assist with audit responses and corrective action implementation resulting from audit findings.
Provide back-up support for complaint intake and complaint investigations as required.