Senior Quality Engineer - Medical Device

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

A growing medical-device manufacturer is hiring a Senior Quality Engineer to help lead quality engineering across new product development, design transfer, manufacturing, and continuous improvement. This is a hands-on senior role for someone who can own technical quality deliverables, influence cross-functional teams, and help strengthen systems at a site that is actively implementing Lean and Six Sigma practices.

This position is fully onsite in Athens, Texas. Candidates must be able to live within a reasonable commuting distance or relocate.

• Lead design-control deliverables, including design plans, inputs and outputs, design reviews, traceability, DHF updates, and DMR readiness.
• Lead and maintain ISO 14971 risk-management activities, including hazard analyses, FMEA, risk controls, and risk-benefit rationale.
• Review and approve verification and validation protocols and reports, including applicable usability, biocompatibility, sterilization, packaging, shelf-life, transportation, and software-validation work.
• Support design transfer and manufacturing readiness through IQ/OQ/PQ, process characterization, CTQ definition, control plans, inspection methods, FAI, pilot builds, and PP events.
• Develop and validate test methods; apply MSA, gage R&R, DOE, sampling, and sound statistical methods to establish acceptance criteria.
• Drive root-cause investigations and CAPA through implementation and effectiveness checks.
• Partner with Manufacturing, Engineering, Regulatory, and supplier teams to prevent defects and improve processes using Lean/Six Sigma tools such as DMAIC, Kaizen, SPC, DOE, and Poka-Yoke.
• Ensure work aligns with FDA and ISO quality-system requirements, including 21 CFR 820, ISO 13485, ISO 14971, and related medical-device standards.
• Provide quality input to regulatory submissions and technical files as needed.
• 8+ years of Quality Engineering experience.
• Experience in an FDA- and ISO-regulated environment; medical-device experience is strongly preferred.
• Demonstrated ownership of design controls, risk management, V&V, and design-transfer activities.
• Strong working knowledge of CAPA, root-cause analysis, IQ/OQ/PQ, statistical methods, and continuous-improvement tools.
• CQE and/or CQA certification preferred.
• Clear communication skills and the ability to lead technical work across functions.

Candidates must be authorized to work in the United States without current or future employer-sponsored work authorization. This is a five-day onsite position in Athens, Texas.