Quality Engineer

Job Description

Job Description

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

Industry

Advanced Manufacturing — cGMP Cleanrooms, 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 cleanrooms, 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 <797>/<800> ; 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 tosupport— not as internal certifications, but as product and project requirements:
• cGMP / FDA 21 CFR Parts 210, 211, 820as 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 <797>/<800> 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 customer IQ/OQ/PQ validation.

3. Process & Product Quality Engineering

• Develop and maintain Process FMEAs (PFMEA), Control Plans, and in-process inspection plans; define Critical-to-Quality (CTQ) characteristics for mechanical fabrication, HVAC/MEP integration, electrical systems, cleanroom panel assembly, and equipment build.
• Apply Statistical Process Control (SPC), capability analysis (Cpk/Ppk), and Measurement System Analysis (MSA / Gauge R&R) to stabilize and improve processes.
• Establishand/orsupportinspection and test methods covering weld inspection (AWS D1.1/D1.6, ASME BPE for stainless steel), HEPA filter leak testing (IEST-RP-CC034), pressure-decay testing, and airflow performance verification.
• Perform First Article Inspections (FAI) for new products and after significant design or process changes; read and interpret engineering drawings, GD&T, weld symbols, and schematics.
• Contribute to Design Reviews and DFMEA as the quality and Voice-of-the-Customer partner to Engineering — helping design quality and manufacturability in, while Engineering owns the design.

4. New Product Introduction (NPI) / APQP & Launch Support

• Supportpractices/activitiessimilar toAdvanced Product Quality Planning (APQP) through phase-gate reviews, helping build Control Plans, PFMEAs, and launch-readiness deliverables for new products and major changes.
• Support process validation and run-at-rate, first-article builds, and the containment of launch issues, capturing lessons learned for future programs.

5. Nonconformance, Root Cause & CAPA

• Disposition nonconforming material and participate in the Material Review Board (MRB); accurately document dispositions and drive timely closure.
• Lead root-cause investigations using 8D, 5-Why, Ishikawa/fishbone, and fault-tree analysis, and drive effective, verified CAPA closure.
• Support Supplier Corrective Action Requests (SCARs) where suppliers are the root cause, partnering with Supplier Quality to recover and preventcosts.

6. Supplier Quality & Incoming Inspection Support

• Help define incoming inspection criteria and sampling plans (ANSI/ASQ Z1.4 and Z1.9) for critical materials — cleanroom panels, HEPA/ULPA filters, stainless fabrications, HVAC components, electrical components, and process equipment.
• Support supplier qualification, on-site process audits, and performance scorecards; provide technical support to the receiving-inspection function and partner with the Incoming Inspector to clear holds.
• Conduct trend and root-cause analysis on supplier-driven defects and feed results into supplier corrective action.

7. Lean Manufacturing & Continuous Improvement

• Participate in and facilitate Kaizen events and rapid-improvement workshops targeting defect reduction, cycle-time compression, and flow.
• Support Value Stream Mapping (VSM), 5S, visual management, and standard work across fabrication and assembly areas.
• Apply Six Sigma DMAIC and poka-yoke (mistake-proofing) to reduce process variation, scrap, rework, and warranty cost in high-impact areas (panel fit-up, seal integrity, duct fabrication, stainless finishing).

8. Audit Support & Customer-Facing Quality

• Support the internal audit program and prepare evidence for ISO 9001 surveillance, customer, and notified-body audits; act as a quality contact during customer audits and inspections as assigned.
• Compile quality dossiers, material certifications, weld traceability records, filter certifications, and test-data packages for project closeout and customer commissioning & qualification (CQV).
• Investigate customer complaints and quality escapes with documented containment, correction, and prevention within defined response timelines.

9. Collaboration, Voice of the Customer & Quality Culture

• Partner cross-functionally with Engineering, Operations, Supply Chain, and Project Management to resolve day-to-day design, production, and customer quality issues at the source.

• Model a quality-first culture through visible engagement andGembapresence; support training on GMP awareness, contamination prevention, ESD controls, nonconformance reporting, and documentation practices.
• Guide and mentor quality technicians and inspectors by example, supporting their development (no direct reports).

Qualifications

Education

• Bachelor’s degree in mechanical, Manufacturing, Industrial, Biomedical, Chemical Engineering, or a closely related technical discipline (or equivalent experience).

Experience

• 3–6 years of quality engineering experience in a manufacturing environment; experience with custom-fabricated and integrated systems (structural, mechanical, HVAC, electrical) is strongly preferred.
• Experience in regulated, life-science, or precision-manufacturing sectors is highly valued.Germfree is ISO 9001:2015 certified; candidates who bring rigor from medical device (ISO 13485, 21 CFR 820), pharmaceutical/biotech (cGMP), or aerospace (AS9100) environments are especially encouraged to apply.
• Hands-on experience across the product lifecycle from supplier and incoming quality through in-process control and customer acceptance (FAT/SAT).

Technical Knowledge

• Working knowledge of ISO 9001:2015 QMS requirements; familiarity with ISO 13485 and FDA 21 CFR 210/211/820 is a strong plus.
• Proficiency with core quality tools: FMEA (DFMEA/PFMEA), Control Plans, SPC, MSA/Gauge R&R, APQP, PPAP, 8D, and CAPA.
• Lean Six Sigma experience (VSM, 5S, Kaizen, DMAIC, poka-yoke); Green Belt preferred.
• Ability to read and interpret engineering drawings, GD&T, weld symbols, and schematics; familiarity with ISO 14644 cleanroom classification.
• Familiarity with weld inspection standards (AWS, ASME BPE), HEPA filter test standards (IEST-RP-CC034), and cleanroom qualification protocols is a plus.

Preferred Qualifications & Certifications

• ASQ Certified Quality Engineer (CQE); Certified Quality Auditor (CQA) or Certified Supplier Quality Professional (CSQP) a plus.
• Lean Six Sigma Green Belt or Black Belt (LSSGB / LSSBB).
• Experience in medical device (ISO 13485), pharmaceutical/biotech (cGMP), or aerospace (AS9100) regulated manufacturing.
• Exposure to modular, prefabricated, or off-site construction quality programs, and to CDC-NIH BMBL (BSL-2/3/4) containment requirements.

Core Competencies

The following competencies define the behaviors and capabilities critical for success in this role:

Competency

Description

Technical Depth

Hands-on fluency with the materials, processes, and systems in cleanroom and controlled-environment manufacturing — fabrication, weldments, sheet metal, HVAC/MEP integration, electrical, and HEPA/filtration.

Problem-Solving & Root Cause

Disciplined use of 8D, 5-Why, Ishikawa, and fault-tree analysis to find true root cause and drive corrective and preventive action to verify closure.

Data-Driven Decision Making

Apply SPC, capability analysis (Cpk/Ppk), MSA, and quality metrics to diagnose issues and prioritize improvements objectively.

Quality-Systems Rigor

Maintains documentation, records, and traceability to ISO 9001:2015 discipline; understands how heavier-regulated frameworks (ISO 13485, 21 CFR 820, cGMP) raise the bar.

Voice of the Customer

Carries the customer's requirements into design reviews, FMEAs, and control plans; partners with Engineering so quality and manufacturability are built in, not inspected in.

Continuous-Improvement Mindset

Champions lean and defect-prevention; actively reduces scrap, rework, and Cost of Quality through Kaizen, poka-yoke, and standard work.

Cross-Functional Collaboration

Communicates and builds trust across Engineering, Operations, Supply Chain, and Project Management to resolve quality issues at the source.

Accountability & Ownership

Holds self to high standards, follows through on commitments, escalates risk early, and can guide technicians and inspectors by example.

Working Conditions & Physical Requirements

• Split between office and the production floor — fabrication, assembly, and cleanroom areas; observation, collaboration, and inspection are part of the daily rhythm.
• Occasional work in confined or elevated areas during facility inspections; capable of standing for extended periods andlifting upto 25 lbs.
• Travel up to 15% may be required for supplier audits, customer site visits, and FAT/SAT activities.
• Must navigate manufacturing environments safely in compliance with all OSHA and Germfree safety protocols.

We are proud to be an Equal Opportunity Employer committed to fostering a diverse and inclusive workplace. We value and celebrate the unique backgrounds, perspectives, and experiences of all individuals, and we believe that diversity drives innovation and growth. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected status.

We also maintain a drug-free workplace. Offers of employment may be contingent upon the successful completion of a drug screening, in accordance with applicable laws and company policies.