Quality Assurance Manager

1 week ago

Fort Lauderdale, Florida, United States Continental Services Group, Inc. Full time $90,000 - $120,000 per year

We are seeking an experienced 
Quality Assurance Manager

to join our team and strengthen our Quality Systems. This is a 
hands-on role

that will partner closely with staff across all departments to ensure compliance, drive continuous improvement, and prepare the organization for regulatory and customer audits. If you're passionate about CAPA management, SOP development, and ensuring compliance in an FDA-regulated environment, this role offers the chance to make a direct impact.

What You'll Do

  • Lead CAPA & Risk Management:
     Drive corrective and preventive action (CAPA) investigations, assess risk, and ensure effective closure and follow-up.
  • Own SOPs & Document Control:
     Revise, maintain, and oversee controlled documents; collaborate with staff to ensure accuracy and compliance.
  • Conduct Internal Audits:
     Plan and execute audits to FDA, CLIA, ISO 9001, and customer requirements; present findings and corrective actions to leadership.
  • Support Regulatory Readiness:
     Host and support external audits from FDA, ISO, and customers.
  • Train & Educate Staff:
     Deliver training on SOPs, QMS principles, and quality culture expectations.
  • Provide Data & Insights:
     Analyze QMS data, calibration records, and KPIs to identify trends and provide clear reports to management.

What We're Looking For

  • Experience:
     3+ years in Quality Assurance within an FDA-regulated industry (biologicals experience strongly preferred).
  • Technical Skills:
     Hands-on CAPA management, SOP writing/revisions, internal auditing, and quality planning experience.
  • Regulatory Knowledge:
     Familiarity with FDA CFRs, ISO 9001, and CLIA; experience hosting or supporting regulatory inspections.
  • Education:
     Bachelor's degree in a science-related field.
  • Other Skills:
     Strong technical writing, root cause analysis, and communication skills; ability to work independently and collaboratively.
  • Bonus:
     Spanish fluency.

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