IVD Process Quality Engineer – Lean & Compliance

Surf Search; Houston (TX); On-site; USD 90,000 - 135,000; Full time

Job summary

Surf Search is seeking a Process Quality Engineer to support regulatory and manufacturing activities in a regulated IVD environment. You will drive process improvement, validation, and quality systems to ensure FDA and international compliance.

Collaboration across Manufacturing, R&D, Quality, Regulatory, and Supply Chain will be essential to sustain operational excellence. The role requires a Bachelor's in a technical field and 4+ years in process or quality roles within IVD or regulated

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Chemistry, or related technical field.
• 4+ years in Process/Quality/Regulatory roles within an IVD or regulated medical device environment.
• Knowledge of FDA QMSR (21 CFR Part 820), ISO 13485, and European IVDR.
• Experience with process validation, equipment qualification, SPC, CAPA, root cause analysis, and risk management.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Design, develop, and optimize manufacturing processes to improve quality, efficiency, and throughput.
• Develop process documentation, flow diagrams, control plans, and manufacturing procedures.
• Lead Lean Manufacturing and Six Sigma process improvement initiatives.
• Analyze manufacturing metrics such as yield, scrap, Cp/Cpk, and process capability to identify opportunities.
• Maintain traceability documentation and validation records.

Skills

Regulatory knowledge

DOE (Design of Experiments)

CAPA & root cause analysis

Statistical process control

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Life Sciences, Chemistry, or related technical discipline

Job description

Surf Search is seeking a Process Quality Engineer to support regulatory and manufacturing activities in a regulated IVD environment. You will drive process improvement, validation, and quality systems to ensure FDA and international compliance.

Collaboration across Manufacturing, R&D, Quality, Regulatory, and Supply Chain will be essential to sustain operational excellence. The role requires a Bachelor's in a technical field and 4+ years in process or quality roles within IVD or regulated