Senior Hybrid CAPA & Recall Quality Specialist

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

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.