Sr. Quality Systems Specialist- CAPA & Recall

IMRIS; Chaska (MN); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health Insurance

401(k) savings plus matching

Flexible Spending Account

Life Insurance

Disability Insurance

Vision Insurance

Generous PTO

Incentive bonus

Job summary

IMRIS Imaging, Inc. is seeking a Sr. Quality Systems Specialist- CAPA & Recall to lead CAPA, recalls, and related QMS activities in a hybrid role requiring on-site presence at the Chaska, MN headquarters three days a week.

The ideal candidate will have a strong background in CAPA, recalls, regulatory affairs, and quality systems, with extensive knowledge of global medical device regulations and experience supporting regulatory inspections and audits.

Qualifications

• 5–8 years in Quality Assurance, Quality Systems, Regulatory Affairs in medical devices or regulated industry.
• Experience managing CAPAs, nonconformances, recalls, advisory notices, field actions, complaints, or quality processes.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, MDSAP, EU MDR, and Canadian Medical Device Regulations.

Responsibilities

• Administer CAPA process day-to-day and coordinate activities from initiation through closure.
• Lead CAPA investigations, root-cause analyses, corrective actions, and effectiveness verification.
• Coordinate recalls, advisory notices, and field actions per procedures and regulatory requirements.
• Prepare status reports and metrics for Quality Management Reviews and regulatory inspections.
• Assist with audit responses and CAPA implementation from audit findings.
• Provide records for internal, external, and regulatory audits as needed.

Skills

CAPA & recalls

Regulatory affairs

Quality systems

Root cause analysis

Audits & inspections

Documentation & records

Cross-functional collaboration

Quality metrics

Regulatory knowledge

Education

Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or related discipline

Tools

Microsoft Office

Job description

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.

JOB SUMMARY

The CAPA & Recall Coordinator is responsible for the administration, coordination, and continual improvement of the Corrective and Preventive Action (CAPA), Field Actions/Recalls, Health Hazard Evaluations, and related Quality Management System (QMS) processes. This role ensures activities are executed in compliance with applicable regulatory requirements, internal procedures, and quality standards.

The position partners with cross-functional stakeholders to facilitate investigations, root cause analysis, corrective actions, effectiveness verification, product recalls, advisory notices, and field actions. The CAPA & Recall Coordinator maintains quality records, develops metrics, supports regulatory inspections and audits, and drives timely resolution of quality system activities.

ESSENTIAL DUTIES AND 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 elevate 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.

SUPERVISION RECEIVED AND EXERCISED

• Reports to the VP of Operations, Customer Service & QARA
• This position does not directly supervise employees.
• May lead cross-functional teams during CAPA investigations, recalls, advisory notices, and field actions.

KNOWLEDGE, SKILLS, AND ABILITIES 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.

IMRIS offers a competitive & comprehensive benefits package that includes:

• Health Insurance
• 401(k) savings plus matching
• Flexible Spending Account
• Life Insurance
• Disability Insurance
• Vision Insurance
• Generous PTO
• Incentive bonus

Compensation Disclaimer:

The actual rate of pay offered within this range may depend on several factors, such as skills, knowledge, relevant education, experience, and market conditions. Additionally, our organization values pay equity and considers the internal equity of our team when making any offer. Hiring at the maximum of the range is not typical.

IMRIS is an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, age, pregnancy, national origin, physical or mental disability, genetics, sexual orientation, gender identity, veteran status, or any other legally-protected status.