Quality Assurance Supervisor- Miami

FloodGate Medical • Tampa, FL

18h • $70,000 - $80,000 • Onsite

About The Position

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.

Requirements

• High school diploma or equivalent required
• 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

Nice To Haves

• Technical/Associate’s degree preferred
• ASQ certification (e.g., CQT, CQI, CQPA) a plus

Responsibilities

• 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
• Initiate and release NCMRs
• Support/document NCMR, CAPA and preventive actions
• Coordinate MRB activities and track effectiveness
• 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
• Manage training process
• Maintain training records and assess training effectiveness
• Plan, coordinate, and direct equipment management to ensure effective maintenance, calibration, and qualification of inspection tools
• Identify/segregate outofcalibration or outofservice equipment and ensure timely remediation
• Oversee daily environmental monitoring for critical systems (e.g., DI water, cleanroom) and escalate out of tolerance conditions
• Maintain supplier quality files, forms, and ERP master data
• Help monitor supplier performance and support qualification/audits as needed
• Support internal/external audits
• Compile/analyze quality metrics for inspections, NCM/CAPA, training, calibration, and document control
• Recommend and drive continuous improvement
• Partner with Operations, Engineering, and Regulatory Affairs to drive compliance, readiness, and right first time quality

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: High school or GED