Quality Engineering Manager: Process Excellence & Compliance

VIVEX Biologics, Inc.; Miami, Northern (FL, KY); Hybrid; USD 120,000 - 165,000; Full time

Job summary

Vivex Biologics, Inc. is seeking a Quality Engineer Manager to lead quality processes across the organization in Miami, FL. You will oversee QA engineers and interns, drive process improvements, and manage validation and equipment qualification efforts.

You will provide regulatory guidance and support supplier qualifications and audits. The role requires a Bachelor's degree in Engineering or related technical field and at least 8 years in engineering or quality, with preference for experience in

Qualifications

• Bachelor's degree in Engineering or related technical discipline is required.
• 8+ years of related Engineering or Quality experience are required.
• Experience in Tissue Banking, Pharmaceutical, Medical Device, or Biologics industry preferred.
• Experience with Non-Conformances, Deviations, Complaints and CAPAs required.
• Experience with Process Validations and Equipment Qualifications.
• Expert knowledge in the interpretation and application of FDA, AATB, and ISO standards and guidelines.
• ASQ certification preferred.
• CTBS certification preferred.
• Must demonstrate effective oral, written, communication and presentation skills.

Responsibilities

• Manage Quality Assurance Engineers and Interns by managing schedules, assigning and prioritizing their workload, establishing due dates, and performing their performance reviews.
• Ensure company is in compliance with all internal policies and procedures and external federal, state, and governing body regulations and standards.
• Responsible for initiating and leading technical investigations, risk assessments (including FMEA, root cause analysis, and corrective and preventive actions related to non-conformances, deviations, and customer complaints).
• Work cross-functionally to provide quality and regulatory guidance to all functional areas in the organization.
• Participate in quality planning activities to evaluate existing and develop new measurement systems to evaluate and improve departmental output.
• Identify process improvement opportunities using Lean principles and lead the development and implementation of process improvements activities.
• Perform pre-validation assessments and review and approval of process validation and equipment qualification (IQ, OQ, PQ protocols and reports).
• Provide support to Regulatory Affairs in the completion of supplier qualifications and audits.
• Other duties as assigned.

Skills

Quality leadership

Regulatory guidance

Process improvement

Communication skills

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in Engineering or related technical discipline

Job description

Vivex Biologics, Inc. is seeking a Quality Engineer Manager to lead quality processes across the organization in Miami, FL. You will oversee QA engineers and interns, drive process improvements, and manage validation and equipment qualification efforts.

You will provide regulatory guidance and support supplier qualifications and audits. The role requires a Bachelor's degree in Engineering or related technical field and at least 8 years in engineering or quality, with preference for experience in