Senior Quality Engineer (LOCAL APPLICANTS PREFERRED)

Senior Quality Engineer (LOCAL APPLICANTS PREFERRED) On-Site, Tempe, AZ12 Month Contract $60/hour W2 Top 3 technical skills that are required for the role:1. Strong background in Equipment Development, IQ/OQ/PQ, and Test Method Development and Validation.2. Critical documentation review with the ability to assess compliance to internal procedures and regulatory requirements using general quality principles, procedures and methodologies3. Understanding of Design Controls and how requirements flow down to process development and validationAbout the OpportunityWe are seeking a Sr. Quality Engineer to support the Unity Diabetes Program at a leading medical device manufacturer in Tempe, AZ. This is an exciting opportunity to partner with engineering and manufacturing teams to ensure quality, compliance, and validation excellence across wafer and sensor manufacturing operations.The ideal candidate will have strong experience supporting process development, equipment validation, quality systems, and manufacturing operations within a regulated medical device environment.Key ResponsibilitiesDevelop, implement, and maintain quality standards, protocols, and procedures for manufacturing processes and products.Ensure manufacturing processes comply with internal procedures, regulatory requirements, and quality standards.Partner with engineering and operations teams to drive quality initiatives and continuous improvement efforts.Support process development and validation activities including: Equipment Development, Installation Qualification (IQ), Process Characterization, Operational Qualification (OQ), Performance Qualification (PQ), and Test Method Development & Validation.Review technical documentation to ensure compliance with quality and regulatory requirements.Support development of validation plans, protocols, and reports using statistical methods and sound quality engineering principles.Facilitate risk management activities including Process FMEA and risk assessments.Lead and support investigations of nonconforming materials, products, and processes.Drive CAPA activities, effectiveness verifications, and root cause investigations.Support change control activities and collaborate with cross-functional stakeholders on implementation strategies.Monitor and report quality metrics, performance scorecards, and improvement initiatives.Participate in design transfer activities to ensure manufacturing processes support product quality requirements.QualificationsRequired Education & ExperienceBachelor's Degree in Engineering, Science, or related technical field plus 4+ years of relevant Engineering and/or Quality experience; OR Master's Degree in Engineering, Science, or related technical field plus 2+ years of relevant experience; OR PhD in Engineering, Science, or related technical field.Required ExperienceMedical device, regulated manufacturing, or related industry experience.Experience supporting process validation and manufacturing quality initiatives.Knowledge of Design Controls, risk management, and quality system requirements.Experience with nonconformance investigations, CAPA, and change control.Strong technical writing, documentation review, and compliance assessment skills.Working knowledge of statistical techniques including DOE, acceptance criteria, and comparison testing.Preferred QualificationsExperience supporting diabetes, sensor, semiconductor, wafer fabrication, or advanced manufacturing products.Familiarity with FDA, ISO 13485, and GMP-regulated environments.Strong cross-functional collaboration and project leadership experience.