Staff Quality Engineer

Staff Quality EngineerKelly Science and Clinical FSP is currently seeking a Quality Engineer for a hybrid role in Irvine, California supporting our Medical Device client. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you will be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time.This position will be hybrid onsite in Irvine, CA with travel to San Diego once a month.The Staff Quality Engineer is an experienced quality leader responsible for driving quality system effectiveness, continuous improvement initiatives, and cross-functional projects that support regulatory compliance and business objectives. This individual serves as a subject matter expert in quality systems and quality tools, providing guidance, risk-based decision making, and project leadership across complex initiatives.Experience:Bachelor's degree in Engineering, Life Sciences, Quality, or related field.4+ years of experience in Medical Device, Pharmaceutical, Biotech, or regulated healthcare industries.Demonstrated experience leading complex quality and compliance initiatives.Experience supporting regulatory inspections, audits, and quality system management.Experience working in cross-functional teams and managing multiple projects simultaneously.Technical Skills:Strong understanding of Quality Management Systems (QMS) and applicable regulations (e.g., ISO 13485, FDA 21 CFR Part 820/QMSR, MDSAP, GMP).Proficient in quality tools and methodologies, including:CAPARisk Management (ISO 14971)Root Cause AnalysisFMEA/PFMEAStatistical Analysis and TrendingProcess MappingFishbone Diagram5 WhysControl PlansInternal AuditingExperience with data analysis, KPI development, and management reporting.Strong project management skills, including planning, execution, risk management, and stakeholder engagement.Proficiency with Microsoft Office Suite, especially Excel, PowerPoint, and data visualization tools.Preferred Training / Certifications:ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent.Project Management Professional (PMP) certification or equivalent project management training.Lean Six Sigma Green Belt or Black Belt preferred.Internal Auditor and/or Lead Auditor training.Risk Management training (ISO 14971) preferred.Leadership & Soft Skills:Strong analytical, problem-solving, and critical-thinking skills.Ability to influence without direct authority and effectively lead cross-functional teams.Excellent written and verbal communication skills.Strong organizational and prioritization abilities.Ability to present complex information to leadership and diverse stakeholders.Demonstrated ownership, accountability, and results-oriented mindset.Skilled at mentoring, coaching, and developing team members.Adaptability and ability to manage ambiguity in a fast-paced environment.Key Responsibilities:Lead strategic quality and compliance initiatives.Facilitate risk assessments and drive risk-based decision making.Analyze quality data and identify opportunities for improvement.Support internal and external audits, inspections, and regulatory activities.Lead complex investigations, CAPAs, and continuous improvement programs.Manage cross-functional projects to ensure timely execution and sustainable results.Provide quality expertise and guidance to business partners and leadership. Kelly