Manager, Quality Engineer

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

Job purpose

The Quality Engineer Manager will be responsible for developing, revising, and maintaining Quality processes, procedures, and metrics to support all functional areas at Vivex Biologics, Inc. This individual will be responsible for providing Quality guidance in process improvement and technology transfer efforts. The Quality Engineer Manager will oversee Quality Engineers and Interns in their day to day tasks as well as the timely completion of projects. This role will also be responsible for reviewing and approving process validation and equipment qualification (IQ, OQ, PQ protocols and reports. The Quality Engineer Manager is also expected to provide support to the Regulatory Affairs team by providing guidance with standards and regulations requirements for supplier qualifications, certifications and licensing, and audits.

Duties and responsibilities

1. Manage Quality Assurance Engineers and Interns by managing schedules, assigning and prioritizing their workload, establishing due dates, and performing their performance reviews.
2. Ensure company is in compliance with all internal policies and procedures and external federal, state, and governing body regulations and standards.
3. 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.
4. Work cross-functionally to provide quality and regulatory guidance to all functional areas in the organization.
5. Participate in quality planning activities to evaluate existing and develop new measurement systems to evaluate and improve departmental output.
6. Identify process improvement opportunities using Lean principles and lead the development and implementation of process improvements activities.
7. Perform pre-validation assessments and review and approval of process validation and equipment qualification (IQ, OQ, PQ protocols and reports.
8. Provide support to Regulatory Affairs in the completion of supplier qualifications and audits.
9. Other duties as assigned.

Requirements

Qualifications

1. A minimum of a Bachelor's degree in Engineering or a related technical discipline is required (e.g. Biology, Chemistry, etc..
2. A minimum of 8 years of related Engineering or Quality experience is required.
3. Experience in Tissue Banking, Pharmaceutical, Medical Device, or Biologics industry preferred.
4. Experience with Non-Conformances, Deviations, Complaints and Corrective and Preventive Actions (CAPAs) required.
5. Experience with Process Validations and Equipment Qualifications.
6. Expert knowledge in the interpretation and application of FDA, AATB, and ISO standards and guidelines.
7. American Society for Quality (ASQ) certification preferred.
8. Certified Tissue Bank Specialist (CTBS) certification preferred.
9. Must demonstrate effective oral, written, communication and presentation skills.

Working conditions

Must be willing to work weekends and evening hours as necessary. Must be willing to accommodate travel if necessary. The job may require work to be performed inside the controlled cleanroom manufacturing area where the engineer would be exposed to tissue processing.

Physical requirements

While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move objects weighing up to 30 pounds.

Direct reports

Quality Assurance Engineers and Interns