Validation Quality Engineer Medical Device

Company DescriptionSARACA is a global engineering R&D services company, supporting 25+ Fortune 500 customers across industries including MedTech, Aerospace, Rail, Automotive, Semiconductor, and Defense. With ISO 13485 certification and expertise in embedded software, UI/UX, mechanical systems, and product testing, SARACA is a trusted partner for developing next-generation innovative medical devices. The company specializes in regulatory compliance, including IEC 62304, EU MDR, and scientific writing for MedTech. With over 400 skilled engineers and management consultants, SARACA delivers innovative solutions to complex business challenges worldwide. As an equal-opportunity employer, SARACA fosters a culture of innovation, learning, and growth for its employees.Role DescriptionThis is a contract, on-site role for a Validation Quality Engineer located in Acton, MA. The Validation Quality Engineer will be responsible for ensuring compliance with quality standards through quality engineering, validation, and testing processes. Daily tasks include implementing quality assurance protocols, performing quality control checks, managing quality performance, and conducting audits to ensure product quality and compliance with industry regulations.Key Responsibilities:pFMEA Review & RemediationDHR Review & Failure AnalysisSOP / Controlled Document UpdatesCAPA & Root Cause InvestigationsRisk Assessments & Nonconformance SupportFDA / ISO 13485 / GMP ComplianceCross-functional Collaboration with QA, Engineering & ManufacturingQuality Remediation & Process Improvement ActivitiesRequired Skills:• Strong experience in Quality Engineering within Medical Device or regulated environments• Hands-on experience with FDA, ISO 13485, and GMP regulations• Knowledge of FMEA, SPC, 8D, QC tools, and validation activities• Experience with DHR review, risk assessments, and technical documentation• Proficiency in Excel, Minitab, or similar data analysis tools• Excellent communication and documentation skillsPreferred:• Experience with supplier quality, audits, or medical device registrations• Continuous improvement mindset with strong analytical skills📩 If interested, please share your updated resume. Referrals are always appreciated!#Hiring #QualitySystemsEngineer #QualityEngineer #MedicalDevice #ISO13485 #FDA #CAPA #GMP #FMEA #DHR #Validation #QualityAssurance #ActonMA #EngineeringJobs #MedicalDeviceJobs