Sr Design Quality Engineer

Sr Quality Engineer – Medical DeviceJob Title: Sr Quality Engineer – Medical DeviceJob Location: Northridge, California (Fully Onsite)Employment Type: W2 contractDuration: 12 monthsMust-Have SkillsDesign Control and Regulatory Experience (ISO 13485, 21 CFR 820, EU-MDR, MDD)Risk Management and Validation ProficiencyImplantable / Electro-Mechanical Device ExperienceGood to Have SkillsWorking knowledge of IEC 62304 and IEC 60601-1Ability to drive process improvement activitiesASQ Certification in Quality or ReliabilityAbility to multi-task, prioritize, meet/exceed deadlines and hold themselves and others accountableEducation Required: Bachelor's degree in engineering or science with 5+ years of work experience in Quality and/or Engineering OR master's degree in engineering or science with 3+ years of work experience in Quality and/or EngineeringMinimum Experience: 3 years of work experienceEssential Functions and ResponsibilitiesProvide quality engineering support throughout the product development lifecycle by applying ISO 13485, ISO 14971, and FDA design control principles to ensure compliance.Serve as a Subject Matter Expert and own Risk Management (Hazards Analysis and FMEAs) across the assigned product / product families (mainly complex electro‑mechanical devices).Support design verification, validation, and reliability testing.Identify and implement effective process control systems to support the development, qualification, and ongoing manufacturing of products to meet or exceed internal and external requirements, supporting design transfer activities.Apply sound, systematic problem‑solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.Support audits, CAPA investigations, and continuous improvement initiatives.Minimum RequirementsDetailed knowledge of FDA 21CFR 820, GMP, MDD and EU‑MDR, and ISO 13485 and ISO 14971.Engineering and technical experience and demonstrated use of Quality tools/methodologies.Experience with planning and executing design verification testing, test method development and test method validation (hands‑on execution experience preferred).Ability to author technical reports, business correspondence and standard operating procedures.Experience with planning and executing process validations (TMV, IQ/OQ/PQ) including authoring of Master Validation Plans and Reports.Seniority LevelMid‑Senior levelEmployment typeContractJob FunctionQuality AssuranceIndustryMedical Equipment Manufacturing and Engineering Services#J-18808-Ljbffr