Quality Systems Expert - Medical Devices (CAPA & Audits)

Real; Burnsville (MN); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Comprehensive benefits package

Job summary

Real, a medical device manufacturer, seeks a Quality Systems Specialist II to maintain the QMS in a regulated environment. You will work on CAPA, nonconformance, audits, document control, change management, training, and quality metrics to ensure compliance and drive improvement.

The role requires collaboration across functions, FDA/ISO-regulated experience, and the ability to manage multiple priorities in a fast-paced setting. On-site in Burnsville, MN with a comprehensive benefits package.

Qualifications

• Experience with CAPA investigations and quality investigations.
• Experience in FDA 21 CFR Part 820, ISO 13485 or similar regulatory environments.
• Strong data analysis, reporting, and quality metrics abilities.

Responsibilities

• Maintain and improve quality system procedures to ensure regulatory compliance.
• Participate in audits and support audit readiness activities.
• Lead or support CAPA investigations and ensure timely resolution of quality issues.
• Conduct root cause investigations and implement corrective and preventive actions.
• Facilitate CAPA meetings and communicate status to stakeholders.
• Monitor and analyze quality metrics, identify trends, and propose improvements.
• Support document control, change management, and engineering change processes.
• Maintain eQMS processes and records.
• Provide training on quality system requirements and best practices.
• Partner with cross-functional teams to ensure product lifecycle quality.

Skills

CAPA

Nonconformance

Audits

Documentation

Data analysis

Root cause

Quality metrics

Education

Bachelor's degree in Engineering/Life Sciences/Quality

Tools

eQMS

Job description

Real, a medical device manufacturer, seeks a Quality Systems Specialist II to maintain the QMS in a regulated environment. You will work on CAPA, nonconformance, audits, document control, change management, training, and quality metrics to ensure compliance and drive improvement.

The role requires collaboration across functions, FDA/ISO-regulated experience, and the ability to manage multiple priorities in a fast-paced setting. On-site in Burnsville, MN with a comprehensive benefits package.