Quality Engineer

Kelly 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:
  • CAPA
  • Risk Management (ISO 14971)
  • Root Cause Analysis
  • FMEA/PFMEA
  • • Statistical Analysis and Trending
    • Process Mapping
    • Fishbone Diagram
    • 5 Whys
    • Control Plans
    • Internal Auditing
  • Experience 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.