Quality Systems Lead – CAPA & Compliance

Imricor Co; Burnsville, Northern (MN, KY); Hybrid; USD 75,000 - 110,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Health Savings Account

Job summary

Imricor is seeking a Quality Systems Specialist II to support a compliant quality management system at our Burnsville, MN site. You will manage CAPA, audits, change control, document control, training, and quality metric review to ensure product quality across the lifecycle.

The role requires 3–5 years in medical device QA, strong data analysis, and knowledge of CFR 820/ISO13485. You will collaborate cross-functionally and provide guidance on best practices.

Qualifications

• 3–5 years of experience in quality assurance or quality systems in the medical device industry.
• Experience with CAPA and nonconformance.
• Knowledge of 21 CFR Part 820, ISO 13485, EU MDR and global regulatory requirements.
• Advanced data analysis and report writing skills.
• Strong verbal and written communication skills.

Responsibilities

• Develops and maintains quality system procedures to ensure compliance with regulations and industry standards.
• Participates in internal and external quality audits to ensure regulatory compliance.
• Participates in, or leads, the completion of CAPA projects, assuring compliance, quality, and timeliness of records.
• Investigate and resolve quality issues, including root cause analysis and implementing corrective and preventive actions.
• Leads meetings and communications for CAPA updates, information, and concerns.
• Monitors and analyzes quality metrics to identify areas for improvement and initiate corrective actions.
• Provides backup support for engineering change orders and other document change requests.
• Develops and maintains electronic quality management system processes. Provides cross-functional training and support as needed.
• Collaborates with cross-functional teams to ensure quality standards are met throughout the product lifecycle.
• Communicates quality system updates and changes to relevant stakeholders.Provides guidance and training to the organization on quality system requirements and best practices.
• Performs other duties as assigned.

Skills

CAPA processes

Nonconformance handling

Internal and External Audits

Document and Records Management

Change Control

Training program development

Quality metrics analysis

Root cause analysis

Cross-functional collaboration

Attention to detail

Education

Bachelor’s degree in a related technical field

Tools

Quality management software

Statistical analysis tools

Job description

Imricor is seeking a Quality Systems Specialist II to support a compliant quality management system at our Burnsville, MN site. You will manage CAPA, audits, change control, document control, training, and quality metric review to ensure product quality across the lifecycle.

The role requires 3–5 years in medical device QA, strong data analysis, and knowledge of CFR 820/ISO13485. You will collaborate cross-functionally and provide guidance on best practices.