Quality Engineer
Listed on 2026-07-15
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Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist, Quality Control - QC Analysts/Managers, Production QC/QA
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Quality EngineerFull Time - 4x 10's Ormond Beach, FL, US
7 days ago Requisition
GERMFREE | Quality Engineering — Job Description
Job Title:
Quality Engineer
· Department:
Quality Engineering
·
Location:
Ormond Beach, FL (USA)
· Classification:
Full-Time, Exempt
Reports To
Director of Quality & Lean (direct report)
FLSA Status
Exempt
Travel
Up to 15% (domestic; occasional international) for supplier audits, customer site visits, and FAT/SAT activities
Advanced Manufacturing — cGMP Clean rooms, Biocontainment Labs, Pharmaceutical Isolators, Biosafety Cabinets, Modular & Mobile Controlled Environments
Position Summary
The Quality Engineer is a hands-on technical contributor who executes, maintains, and continuously improves quality across Germfree's advanced manufacturing operations. Germfree engineers manufacture mission-critical controlled environments; modular and mobile cGMP clean rooms, biosafety level (BSL-2 through BSL-4) biocontainment laboratories, pharmaceutical isolators, biosafety cabinets, laminar-flow workstations, and compounding-pharmacy solutions for biopharmaceutical, healthcare, and biocontainment customers worldwide.
Reporting directly to the Director of Quality & Lean, this individual-contributor role applies engineering rigor across the full product lifecycle: supplier and incoming quality, process and in-process control, new product introduction (NPI/APQP), nonconformance and root-cause investigation, and Factory/Site Acceptance Testing (FAT/SAT). The Quality Engineer partners closely with Engineering, Operations, Supply Chain, and Project Management carrying the Voice of the Customer into design and build: and may guide quality technicians and inspectors, though the role has no direct reports.
About Germfree's certification & the experience we value
Germfree maintains ISO 9001:2015 certification. Its products are engineered to support a range of customer and industry standards (cGMP / FDA 21 CFR Parts 210, 211, 820; ISO 14644; EU GMP Annex 1; USP /; CDC-NIH BMBL; ISPE/GAMP); these are standards the products must meet for customers, not certifications Germfree holds. We especially welcome candidates who bring experience from more heavily regulated sectors — medical device (ISO 13485, 21 CFR 820), pharmaceutical/biotech (cGMP), or aerospace (AS9100) .
That regulatory discipline translates directly into the quality our customers depend on.
Key Responsibilities
1. Quality Management System (QMS) Support & Documentation
- Execute and help maintain Germfree's ISO 9001:2015 quality management system, supporting conformance across fabrication, assembly, integration, and final acceptance.
- Author and revise Standard Operating Procedures (SOPs), Work Instructions (WIs), Quality Plans, and Inspection & Test Plans (ITPs), and support Document Control for version control, record retention, and traceability.
- Process and track nonconformances (NCMRs), corrective and preventive actions (CAPAs), and disposition records, ensuring complete and audit-ready documentation.
- Compile and report quality metrics;first-pass yield, scrap/rework, escape rate, and Cost of Quality (CoQ) and surface trends with recommended actions to the Director of Quality & Lean.
2. Industry & Customer Regulatory Standards (Applied)
- Apply working knowledge of the customer and industry standards Germfree's products are designed and built to support — not as internal certifications, but as product and project requirements:
- cGMP / FDA 21 CFR Parts 210, 211, 820 as applicable to cleanroom and equipment product lines delivered to pharma and medical customers.
- ISO 14644 (Parts 1–4) cleanroom classification, monitoring, design, and operations.
- EU GMP Annex 1, USP / sterile-product and compounding-pharmacy facility requirements.
- CDC-NIH BMBL (BSL-2/3/4) biocontainment facility requirements; and ISPE Baseline Guides / GAMP 5 for commissioning and qualification documentation.
- Support regulatory documentation for Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) that feeds downstream…
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