Quality Engineer / Validation Engineer

Job Title: Quality Engineer / Validation Engineer (Medical Device)Location: Austin, TXEmployment Type: W2 onlyDuration: 12 Months ContractJob Summary:We are seeking a Senior Quality Engineer / Validation Engineer to support a rapidly growing medical device organization in Austin, TX. The role focuses heavily on equipment and process validation, with strong emphasis on manufacturing operations, risk management, and compliance in an FDA-regulated environment.This is a hands-on role supporting new product development (NPD), tech transfer, facility expansion, and acquisition integration activities, ensuring all quality systems and validations meet regulatory and corporate requirements.Key ResponsibilitiesLead quality engineering activities supporting NPD, tech transfer, and product line expansionsReview, approve, and execute equipment and process validations (IQ/OQ/PQ, TMV)Support validation of machine shop equipment, CMMs, QC inspection systems, and package sealing equipmentPerform GR&R studies, statistical analysis, and acceptance sampling for process qualificationSupport validation activities associated with facility moves and manufacturing transitionsLead investigations for non-conformances, CAPAs, and product complaintsSupport and maintain the Risk Management Program and Risk Management Files (RMFs)Evaluate hazards, risk probability, severity, and mitigation strategiesReview and assess design changes for impact on quality and regulatory compliancePartner with manufacturing, facilities, and supply chain teams for process improvementsSupport internal and supplier audits and ensure compliance with FDA QSR, GMP, and ISO standardsAnalyze post-market quality data including NCRs, complaints, and CAPAsSupport creation and review of Design History File (DHF) documentationRequired QualificationsBachelor’s degree in Engineering or related technical field (or equivalent experience)6+ years of Quality Engineering or Validation Engineering experience in FDA-regulated industry (Medical Device preferred)Strong knowledge of GMP, FDA QSR, and ISO 13485 standardsHands-on experience in equipment and process validation (IQ/OQ/PQ, TMV, GR&R)Strong statistical and analytical skills (acceptance sampling, process capability analysis, etc.)Experience working in manufacturing environments supporting validation and quality systemsStrong experience with CAPA, NCRs, and root cause investigationsPreferred QualificationsASQ CQE or CQA certificationExperience in heart valve, cardiovascular, or high-risk medical device manufacturingStrong risk management experience (FMEA, RMF, risk assessments)Experience supporting facility expansion or manufacturing relocation projects