Quality Assurance Supervisor- Miami

Job Description

This Quality Assurance Supervisor role will involve reviewing incoming, in-process, and final inspections; managing nonconformance and CAPA activities; administering document control; managing training processes; overseeing equipment calibration and environmental monitoring; maintaining supplier quality files; supporting internal/external audits; and partnering with Operations, Engineering, and Regulatory Affairs.

• High school diploma or equivalent required;
  Technical/Associate’s degree preferred.
• ASQ certification (e.g., CQT, CQI, CQPA) a plus.
• Experience in Quality or Manufacturing in a medical device or regulated manufacturer.
• Working knowledge of FDA QSR (21
  
  CFR
  820), ISO
  13485, ISO
  14971; familiarity with ANSI/ASQ Z1.4 (sampling) preferred.
• Hands on use of inspection tools; ability to read/interpret mechanical drawings and collect/record inspection data.
• Experience with document control/change control in an electronic QMS; proficiency with Microsoft 365/ERP.

• Inspection & Records:
  Review incoming, in process/first article, and final inspections of mechanical and electromechanical medical devices/components using optical and mechanical tools; review DHRs/Travelers for completeness and compliance.
• Nonconformance/CAPA:
  Initiate and release NCMRs; support/document NCMR, CAPA and preventive actions; coordinate MRB activities and track effectiveness.
• Quality System & Document Control:
  Administer document control (policies, SOPs, work instructions, inspection plans, training materials, numbering, version control, distribution); coordinate change orders and periodic reviews; maintain compliance to FDA QSR/21
  
  CFR
  820,
  ISO
  13485, ISO
  14971, and applicable standards.
• Training:
  Manage training process. Maintain training records and assess training effectiveness.
• Equipment & Calibration:
  Plan, coordinate, and direct equipment management to ensure effective maintenance, calibration, and qualification of inspection tools; identify/segregate out of calibration or out of service equipment and ensure timely remediation.
• Environmental/Facility Monitoring:
  Oversee daily environmental monitoring for critical systems (e.g., DI water, cleanroom) and escalate out of tolerance conditions.
• Supplier Management:
  Maintain supplier quality files, forms, and ERP master data; help monitor supplier performance and support qualification/audits as needed.
• Audits & Metrics:
  Support internal/external audits; compile/analyze quality metrics for inspections, NCM/CAPA, training, calibration, and document control; recommend and drive continuous improvement.
• Cross functional Support:
  Partner with Operations, Engineering, and Regulatory Affairs to drive compliance, readiness, and right first time quality.

• Base salary: $70K–$80K
• 401(k): 5% company match, 100% immediate vesting
• Healthcare: 100% covered for employees, 80% covered for spouse and dependents
• HSA: $1,500 annual employer contribution
• Vision & Dental: Standard coverage
• Paid Time Off: Two weeks of vacation plus one week of sick time

• Territory Parameters:
  Miami, FL
• Acceptable Candidate
  
  Location:
  
  Miami Lakes, Florida. The individual must be comfortable commuting to the office Monday through Friday.