Manager, Quality Engineer

About the role

The Quality Engineer Manager will develop, revise, and maintain Quality processes, procedures, and metrics to support all functional areas at Vivex Biologics, Inc. This individual will provide Quality guidance in process improvement and technology transfer efforts, oversee Quality Engineers and Interns, and ensure timely completion of projects. The role includes reviewing and approving process validation and equipment qualification (IQ, OQ, PQ protocols and reports) and supporting the Regulatory Affairs team with standards and regulations for supplier qualifications, certifications, licensing, and audits.

Responsibilities

• Manage Quality Assurance Engineers and Interns by assigning and prioritizing workload, establishing due dates, and conducting performance reviews.
• Ensure company compliance with all internal policies, procedures, and external federal, state, and governing body regulations and standards.
• Initiate and lead 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 and develop new measurement systems for improving departmental output.
• Identify process improvement opportunities using Lean principles and lead the development and implementation of process improvements.
• Perform pre-validation assessments and review and approve process validation and equipment qualification (IQ, OQ, PQ protocols and reports).
• Support Regulatory Affairs in completing supplier qualifications and audits.
• Perform other duties as assigned.

Requirements

• A minimum of a Bachelor's degree in Engineering or a related technical discipline (e.g., Biology, Chemistry).
• At least 8 years of related Engineering or Quality experience.
• Experience in Tissue Banking, Pharmaceutical, Medical Device, or Biologics industry preferred.
• Experience with Non-Conformances, Deviations, Complaints, and Corrective and Preventive Actions (CAPAs).
• Experience with Process Validations and Equipment Qualifications.
• Expert knowledge in interpreting and applying FDA, AATB, and ISO standards and guidelines.
• American Society for Quality (ASQ) certification preferred.
• Certified Tissue Bank Specialist (CTBS) certification preferred.
• Effective oral, written, communication, and presentation skills.

Working Conditions

• Willingness to work weekends and evening hours as necessary.
• Willingness to accommodate travel if required.
• May require work inside a controlled cleanroom manufacturing area with exposure to tissue processing.

Physical Requirements

• Regularly required to sit for prolonged periods.
• May occasionally need to pull, lift, and/or move objects weighing up to 30 pounds.

Direct Reports

Quality Assurance Engineers and Interns.