Quality Engineer

Kelly Science, Engineering, Technology & Telecom; Irvine (CA); Hybrid; USD 95,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401K

Paid time off

Job summary

Kelly Science and Clinical FSP in Irvine, CA is seeking a Staff Quality Engineer for a hybrid role supporting a medical device client. You will lead quality system effectiveness, drive continuous improvement, guide risk-based decisions, and partner with cross-functional teams to meet regulatory obligations under ISO 13485, FDA 21 CFR Part 820, and MDSAP.

The position offers full benefits (medical, dental, vision, 401K) and paid time off.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, or related field.
• 4+ years in Medical Device or regulated healthcare industries.
• Experience leading quality/compliance initiatives.
• Experience supporting regulatory inspections and audits.

Responsibilities

• Lead strategic quality and compliance initiatives.
• Facilitate risk assessments and drive risk-based decisions.
• Analyze quality data and identify improvement opportunities.
• Support audits, inspections, and regulatory activities.
• Lead investigations, CAPAs, and continuous improvement programs.
• Manage cross-functional projects to ensure timely execution.
• Provide quality guidance to leadership and partners.

Skills

QMS knowledge

Regulatory awareness

Data analysis

Cross-functional leadership

Project management

Quality tools

Statistical analysis

Process mapping

Auditing

Communication skills

Education

Bachelor's degree in Engineering/Life Sciences/Quality

Tools

Minitab

Excel

JMP

Quality management software

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.

• ExperienceBachelor'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 SkillsStrong 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
• 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.
• 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.