Quality Systems Specialist II

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

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, colour, 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.