Quality Engineer: Regulated Life-Science Manufacturing

Evolving Solution Services; Ormond Beach (FL); On-site; USD 75,000 - 115,000; Full time

Job summary

Germfree in Ormond Beach, FL seeks a Quality Engineer to ensure quality across advanced manufacturing operations, from incoming quality to FAT/SAT. You will collaborate with Engineering, Operations, Supply Chain, and Project Management to drive CAPAs and process improvements.

The ideal candidate has 3–6 years in quality engineering in regulated environments, with strong knowledge of GMP and ISO standards and the ability to read engineering drawings and implement QMS practices.

Qualifications

• Bachelor's degree in engineering or closely related technical discipline.
• 3–6 years of quality engineering experience in manufacturing.
• Experience with ISO 9001 and regulatory frameworks (cGMP, FDA 21 CFR 210/211/820) preferred.
• Ability to read engineering drawings and perform QA/QC activities.

Responsibilities

• Support QMS with SOPs, CAPAs, and document control.
• Lead/participate in PFMEA, Control Plans, and FAT/SAT activities.
• Perform supplier and incoming quality inspections.
• Analyze data and drive continuous improvement.

Skills

Quality Engineering

Regulatory Standards

GMP

Root Cause Analysis

Education

Bachelor's degree in Mechanical/Manufacturing/Industrial/Biomedical/Chemical Engineering

Job description

Germfree in Ormond Beach, FL seeks a Quality Engineer to ensure quality across advanced manufacturing operations, from incoming quality to FAT/SAT. You will collaborate with Engineering, Operations, Supply Chain, and Project Management to drive CAPAs and process improvements.

The ideal candidate has 3–6 years in quality engineering in regulated environments, with strong knowledge of GMP and ISO standards and the ability to read engineering drawings and implement QMS practices.