VIVEX Biologics
Job Purpose
The Quality Engineering 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 provide Quality guidance in process improvement and technology transfer efforts, oversee Quality Engineers and Interns, review and approve process validation and equipment qualification (IQ, OQ, PQ protocols and reports), and support the Regulatory Affairs team with guidance on standards, regulations, supplier qualifications, certifications, licensing, and audits.
Duties & Responsibilities
Manage Quality Assurance Engineers and Interns – schedule, assign, prioritize work, set deadlines, and conduct performance reviews.
Ensure compliance with all internal policies and external regulations.
Initiate and lead technical investigations, risk assessments (FMEA, root‑cause analysis, CAPA for non‑conformances, deviations, and customer complaints).
Work cross‑functionally to provide quality and regulatory guidance to all functional areas.
Participate in quality planning activities to develop measurement systems for continual improvement.
Identify process improvement opportunities using Lean principles and lead implementation of improvements.
Perform pre‑validation assessments and approve process validation and equipment qualification documents.
Support Regulatory Affairs in supplier qualification and audit completion.
Assist with other duties as assigned.
Requirements & Qualifications
Bachelor’s degree in Engineering or related technical discipline.
Minimum 8 years of related engineering or quality experience.
Experience in tissue banking, pharmaceutical, medical device, or biologics preferred.
Experience with non‑conformances, deviations, complaints, CAPAs essential.
Experience with process validations and equipment qualifications.
Expert knowledge of FDA, AATB, and ISO standards and guidelines.
ASQ certification preferred.
CTBS certification preferred.
Excellent oral, written, communication, and presentation skills.
Working Conditions
Must be willing to work weekends and evenings as needed, accommodate travel if necessary. Work may be performed inside a controlled cleanroom where the engineer is exposed to tissue processing.
Physical Requirements
Regularly required to sit for prolonged periods; may occasionally need to lift up to 30 pounds.
Direct Reports
Quality Assurance Engineers and Interns
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Quality Assurance
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The Quality Engineering 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 provide Quality guidance in process improvement and technology transfer efforts, oversee Quality Engineers and Interns, review and approve process validation and equipment qualification (IQ, OQ, PQ protocols and reports), and support the Regulatory Affairs team with guidance on standards, regulations, supplier qualifications, certifications, licensing, and audits.
Duties & Responsibilities
Manage Quality Assurance Engineers and Interns – schedule, assign, prioritize work, set deadlines, and conduct performance reviews.
Ensure compliance with all internal policies and external regulations.
Initiate and lead technical investigations, risk assessments (FMEA, root‑cause analysis, CAPA for non‑conformances, deviations, and customer complaints).
Work cross‑functionally to provide quality and regulatory guidance to all functional areas.
Participate in quality planning activities to develop measurement systems for continual improvement.
Identify process improvement opportunities using Lean principles and lead implementation of improvements.
Perform pre‑validation assessments and approve process validation and equipment qualification documents.
Support Regulatory Affairs in supplier qualification and audit completion.
Assist with other duties as assigned.
Requirements & Qualifications
Bachelor’s degree in Engineering or related technical discipline.
Minimum 8 years of related engineering or quality experience.
Experience in tissue banking, pharmaceutical, medical device, or biologics preferred.
Experience with non‑conformances, deviations, complaints, CAPAs essential.
Experience with process validations and equipment qualifications.
Expert knowledge of FDA, AATB, and ISO standards and guidelines.
ASQ certification preferred.
CTBS certification preferred.
Excellent oral, written, communication, and presentation skills.
Working Conditions
Must be willing to work weekends and evenings as needed, accommodate travel if necessary. Work may be performed inside a controlled cleanroom where the engineer is exposed to tissue processing.
Physical Requirements
Regularly required to sit for prolonged periods; may occasionally need to lift up to 30 pounds.
Direct Reports
Quality Assurance Engineers and Interns
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Quality Assurance
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