On-Site Quality Systems Specialist II - CAPA & QMS Lead

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

Benefits offered by this job

Comprehensive benefits package

Paid leave and health coverage

Job summary

Real Staffing is seeking a Quality Systems Specialist II in Burnsville, MN to maintain and improve the QMS under FDA and ISO regulation. You will lead CAPA, change control, document management, audits, and quality metrics across engineered medical device products.

The role requires 3–5 years in medical device quality systems, strong analytical and communication skills, and collaboration across functions to drive continuous improvement and operational excellence.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality or a related technical field.
• 3-5 years of experience in Quality Systems or QA within medical device industry.
• Experience with CAPA, nonconformance management and quality investigations.
• Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, EU MDR and other regulatory requirements.
• Experience using quality tools and root cause analysis.
• Strong analytical skills with data analysis and metrics.
• Excellent written and verbal communication skills.
• Strong organizational skills and ability to manage multiple priorities.

Responsibilities

• Maintain and improve quality system procedures to ensure regulatory/commercial compliance.
• Participate in internal/external audits and support audit readiness.
• Lead or support CAPA investigations and ensure timely resolution of quality issues.
• Conduct root cause analyses and implement corrective/preventive actions.
• Facilitate CAPA meetings and communicate status, risks, and outcomes.
• Monitor and analyze quality metrics; identify trends and improvement opportunities.
• Support document control, change management, and engineering change processes.
• Maintain and improve electronic Quality Management System (eQMS) processes and records.
• Provide training/guidance on quality system requirements and best practices.
• Collaborate across functions to ensure quality throughout product lifecycle.
• Communicate quality system updates and regulatory requirements organization-wide.
• Perform other quality/compliance duties as needed.

Skills

CAPA investigations

Nonconformance management

Audits

Document control

Change management

Training

Quality metrics

Data analysis

Regulatory knowledge (FDA QSR, ISO 134

Education

Bachelor's degree in Engineering, Life Sciences, Quality, or related field

Tools

eQMS

Job description

Real Staffing is seeking a Quality Systems Specialist II in Burnsville, MN to maintain and improve the QMS under FDA and ISO regulation. You will lead CAPA, change control, document management, audits, and quality metrics across engineered medical device products.

The role requires 3–5 years in medical device quality systems, strong analytical and communication skills, and collaboration across functions to drive continuous improvement and operational excellence.