Staff Quality Engineer

Kelly Services; Irvine (CA); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401K

Paid time off

Job summary

Kelly Science & Clinical FSP is seeking a Quality Engineer for a hybrid role in Irvine, California. The engineer will drive quality system effectiveness, lead cross-functional projects, and support regulatory compliance for our medical device client.

Ideal candidates have a strong background in QMS, ISO 13485, FDA 21 CFR Part 820, and experience with CAPA, risk management, and data-driven improvement. Hybrid onsite role with occasional travel to San Diego.

Qualifications

• 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.

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.

Skills

CAPA

Risk management

Root cause analysis

FMEA/PFMEA

Statistical analysis

Process mapping

Fishbone diagram

5 whys

Control plans

Internal auditing

Data visualization

KPI reporting

Education

Bachelor's degree in Engineering, Life Sciences, Quality, or related field

Tools

Excel

PowerPoint

MS Office

Data visualization tools

Job description

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.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en) .

Kelly Services is proud to be an Equal Employment Opportunity and Affluent Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.