Quality Engineering Manager: Process Improvement & Compliance

Vivex Biologics; Miami (FL); On-site; USD 120,000 - 170,000; Full time

Job summary

Vivex Biologics, Inc. seeks a Quality Engineer Manager to lead quality assurance, develop and revise quality processes, and supervise engineers and interns. The role focuses on timely project completion, process validation, and equipment qualification.

The position requires a bachelor’s in engineering, 8+ years in related fields, and strong knowledge of FDA, AATB, and ISO standards. Occasional travel and weekend work may be necessary.

Qualifications

• Bachelor's degree in Engineering or related technical field.
• 8+ years of related engineering or quality experience.
• Experience in Tissue Banking, Pharmaceutical, Medical Device, or Biologics preferred.
• Experience with Non-Conformances, Deviations, Complaints and CAPAs.
• Experience with Process Validations and Equipment Qualifications.
• Strong knowledge of FDA, AATB, and ISO standards and guidelines.
• ASQ and CTBS certifications preferred.
• Excellent oral, written, and presentation skills.

Responsibilities

• Oversee Quality Engineers and Interns, manage schedules and performance reviews.
• Ensure compliance with internal policies and external regulations.
• Lead investigations, risk assessments (FMEA), root-cause analysis, and CAPA activities.
• Provide quality and regulatory guidance across functions.
• Support quality planning and measurement systems improvement.
• Drive Lean-based process improvements and equipment qualification reviews.
• Support supplier qualifications and audits, and other duties as assigned.

Skills

Leadership

Communication

Regulatory guidance

Problem solving

Education

Bachelor's degree in Engineering

Job description

Vivex Biologics, Inc. seeks a Quality Engineer Manager to lead quality assurance, develop and revise quality processes, and supervise engineers and interns. The role focuses on timely project completion, process validation, and equipment qualification.

The position requires a bachelor’s in engineering, 8+ years in related fields, and strong knowledge of FDA, AATB, and ISO standards. Occasional travel and weekend work may be necessary.