Quality Systems Specialist II

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

Compensation: $75,000 - $110,000 annually, plus comprehensive benefits package.

About the Opportunity

Location: Burnsville, MN (On-site)

Compensation: $75,000 - $110,000 annually, plus comprehensive benefits package.

About the Opportunity

A medical device manufacturer is seeking a Quality Systems Specialist II to support and maintain an effective Quality Management System (QMS) in a regulated environment. This role is responsible for key quality system processes including CAPA, nonconformance management, audits, document control, change management, training, and quality metrics.

The ideal candidate will have experience working within FDA and ISO-regulated environments and will collaborate across functions to ensure compliance, drive continuous improvement, and support operational excellence.

Key Responsibilities

• Maintain and improve quality system procedures to ensure regulatory and industry compliance.
• Participate in internal and external audits and support audit readiness activities.
• Lead or support CAPA investigations and ensure timely, compliant resolution of quality issues.
• Conduct root cause investigations and implement corrective and preventive actions.
• Facilitate CAPA meetings and communicate status, risks, and outcomes to stakeholders.
• Monitor and analyze quality metrics, identify trends, and recommend improvement initiatives.
• Support document control, change management, and engineering change processes.
• Maintain electronic Quality Management System (eQMS) processes and records.
• Provide training and guidance on quality system requirements and best practices.
• Partner with cross-functional teams to ensure quality standards are maintained throughout the product lifecycle.
• Communicate quality system updates and compliance requirements across the organization.
• Perform additional quality and compliance-related duties as needed.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical field.
• 3-5 years of experience in Quality Systems, Quality Assurance, or a similar role within the medical device industry.
• Experience with CAPA, nonconformance management, and quality investigation processes.
• Working knowledge of FDA Quality System Regulations (21 CFR Part 820), ISO 13485, EU MDR, and other applicable regulatory requirements.
• Experience utilizing quality tools and methodologies, including root cause analysis.
• Strong analytical skills with experience in data analysis, reporting, and quality metrics.
• Excellent written and verbal communication skills.
• Strong organizational skills, attention to detail, and ability to manage multiple priorities in a fast-paced environment.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.