Senior Quality Engineer - Medical Device
PI Search ยท Athens, TX
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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.๐ช๐ต๐ฎ๐ ๐๐ผ๐โ๐น๐น ๐ฑ๐ผLead 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.๐ช๐ต๐ฎ๐ ๐๐ผ๐ ๐ฏ๐ฟ๐ถ๐ป๐ดBachelorโs degree required.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.๐ช๐ผ๐ฟ๐ธ ๐ฎ๐๐๐ต๐ผ๐ฟ๐ถ๐๐ฎ๐๐ถ๐ผ๐ป ๐ฎ๐ป๐ฑ ๐น๐ผ๐ฐ๐ฎ๐๐ถ๐ผ๐ปCandidates 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.