Senior Quality Engineer, Medical Devices: Lead NPD & QA

PI Search; Athens (TX); On-site; USD 90,000 - 125,000; Full time

Job summary

PI Search is seeking a Senior Quality Engineer to lead quality engineering across new product development, design transfer, manufacturing, and continuous improvement at a Texas site. This hands-on role owns technical quality deliverables and drives Lean/Six Sigma initiatives with cross-functional teams.

The position requires 8+ years of experience in a FDA/ISO-regulated environment, ownership of design controls, risk management, V&V, and design-transfer activities.

Qualifications

• 8+ years of Quality Engineering experience in FDA/ISO environment.
• Ownership of design-controls, risk management, V&V, and design-transfer activities.
• Strong CAPA, root-cause analysis and continuous-improvement skills.
• CQE and/or CQA certification preferred.

Responsibilities

• Lead design-control deliverables (plans, inputs/outputs, reviews, traceability, DHF, DMR).
• Lead ISO 14971 risk-management activities (hazard analyses, FMEA, risk controls).
• Review/approve verification and validation protocols and reports (usability, biocompatibility, sterilization, packaging, shelf-life, software validation).
• Support design transfer and manufacturing readiness (IQ/OQ/PQ, process characterization, CTQ, control plans, FAI).
• Develop and validate test methods; apply MSA, gage R&R, DOE and SPC to establish acceptance criteria.
• Drive CAPA implementation and effectiveness checks; lead root-cause investigations.
• Collaborate with Manufacturing, Engineering, Regulatory, and suppliers using Lean/Six Sigma tools (DMAIC, Kaizen, Poka-Yoke).
• Ensure compliance with FDA/ISO requirements (21 CFR 820, ISO 13485, ISO 14971) and contribute to regulatory submissions.

Skills

Quality engineering

CAPA

Root-cause analysis

V&V

Design controls

Lean Six Sigma

DOE

SPC

Tools

MSA

Gage R&R

DOEs

Job description

PI Search is seeking a Senior Quality Engineer to lead quality engineering across new product development, design transfer, manufacturing, and continuous improvement at a Texas site. This hands-on role owns technical quality deliverables and drives Lean/Six Sigma initiatives with cross-functional teams.

The position requires 8+ years of experience in a FDA/ISO-regulated environment, ownership of design controls, risk management, V&V, and design-transfer activities.