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Quality Engineer Remote in irvine, CA, US • Posted 17 hours ago • Updated 5 hours ago Contract W2 On-site Motion Recruitment Partners, LLC Fitment Dice Job Match Score™ 🔢 Crunching numbers... Job Details Skills Science Life Sciences Medical Devices Pharmaceutics Health Care Quality Management

QMS ISO 13485 GMP

Corrective And Preventive Action Root Cause Analysis FMEA Statistics Process Mapping Internal Auditing Data Analysis KPI Management Reporting Stakeholder Engagement Microsoft Office Microsoft Excel Microsoft PowerPoint Data Visualization PMP Project Management Lean Six Sigma Risk Management Training

ISO 9000

Soft Skills Analytical Skill Conflict Resolution Problem Solving Critical Thinking Communication Accountability Mentorship Coaching Adaptability Regulatory Compliance Risk Assessment Decision-making Auditing Continuous Improvement Management Leadership Science Life Sciences Medical Devices Pharmaceutics Health Care Quality Management

QMS ISO 13485 GMP

Corrective And Preventive Action Root Cause Analysis FMEA Statistics Process Mapping Internal Auditing Data Analysis KPI Management Reporting Stakeholder Engagement Microsoft Office Microsoft Excel Microsoft PowerPoint Data Visualization PMP Project Management Lean Six Sigma Risk Management Training

ISO 9000

Soft Skills Analytical Skill Conflict Resolution Problem Solving Critical Thinking Communication Accountability Mentorship Coaching Adaptability Regulatory Compliance Risk Assessment Decision-making Auditing Continuous Improvement Management Leadership Summary 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. Employers have access to artificial intelligence language tools ("AI") that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id:

10105282

Position Id:

885933 Posted 17 hours ago Company Info About Motion Recruitment Partners, LLC Motion Recruitment delivers IT Talent Solutions for Contract, Direct Hire, Managed Solutions and Statement of Work to all of North America from our 21 delivery centers. Our high-touch, specialized, team-based recruitment model's success is proven through our exemplary track record in filling the most challenging IT positions for startup and enterprise clients alike. Our hyper-specialized tech focus results in a truly consultative approach for both our clients and candidates, within our recruiting areas of expertise: Software, Mobile, Data, Infrastructure, Cybersecurity, Product + UX and Functional. Motion also delivers IT Consulting Solutions through the Motion Consulting Group (MCG) that create true digital transformation for IT projects in Agile Development & Coaching, DevOps & DevSecOps Solutions, and Managed Services for IT Operations. We're also the proud creators of Tech in Motion and the Timmy Awards, our North American community platform, events series and award program that connects over 250,000 tech enthusiasts to meet, learn, and innovate.