Quality Engineering Manager: Process Excellence & Compliance

Socket.dev; Miami (FL); On-site; USD 120,000 - 180,000; Full time

Job summary

Vivex Biologics, Inc. seeks a Quality Engineer Manager to lead Quality Engineers and Interns, drive quality systems, and oversee process validation and equipment qualification. The role involves cross-functional collaboration and ensuring adherence to regulatory standards.

Responsibilities include conducting risk assessments, CAPAs, and supplier audits, while guiding regulatory affairs in line with FDA, ISO, and AATB expectations. A BS in engineering and 8+ years in related fields are required.

Qualifications

• Bachelor's degree in Engineering or related technical discipline required.
• 8+ years of related Engineering or Quality experience 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 of FDA, AATB, and ISO standards and guidelines.
• ASQ and CTBS certifications preferred.
• Strong oral, written, and presentation skills.

Responsibilities

• Manage Quality Assurance Engineers and Interns with workload planning and reviews.
• Ensure compliance with internal policies and external regulations.
• Lead technical investigations, risk assessments, CAPAs for non-conformances and complaints.
• Provide cross-functional quality and regulatory guidance across the org.
• Contribute to quality planning and measurement system improvements.
• Identify and lead Lean-based process improvements.
• Oversee pre-validation assessments and review of PQ/IQ/OQ reports.
• Support Regulatory Affairs with supplier qualifications and audits.
• Perform other duties as assigned.

Skills

Quality management

Process improvement

Regulatory guidance

Cross-functional leadership

Communication skills

Presentation skills

Education

Bachelor's degree in Engineering or related field

ASQ certification (preferred)

CTBS certification (preferred)

Job description

Vivex Biologics, Inc. seeks a Quality Engineer Manager to lead Quality Engineers and Interns, drive quality systems, and oversee process validation and equipment qualification. The role involves cross-functional collaboration and ensuring adherence to regulatory standards.

Responsibilities include conducting risk assessments, CAPAs, and supplier audits, while guiding regulatory affairs in line with FDA, ISO, and AATB expectations. A BS in engineering and 8+ years in related fields are required.