Quality Engineer

About the role

Kelly Science and Clinical FSP is seeking a Quality Engineer for a hybrid role in Irvine, California supporting a Medical Device client. The role is full‑time with Kelly FSP (Functional Service Provider) division, a managed solution provider of Kelly Services, Inc. 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. The position is hybrid onsite in Irvine, CA with travel to San Diego once a month.

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.

Requirements

• 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.

Qualifications

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.

Skills

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.

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.

Benefits

• Medical, Dental, Vision, 401K and a variety of other benefit options.
• Paid time off, including holiday, vacation, and sick/personal time.

Schedule

Hybrid onsite in Irvine, CA with travel to San Diego once a month.

Posted By: Brendan Bartosiewicz