Quality Engineer I

3 weeks ago


Irvine, United States The Judge Group Full time

Position Title: Quality Engineer I
Duration: Contract
Work Location: Irvine, CA
Job Duties:
Develops and executes plans for quality and control to ensure manufacturing continuity and product conformance.
Leads investigations into production and customer-facing quality issues to identify root cause, implement corrective and preventative actions, and monitor effectiveness
Monitors and analyses product performance of medical devices using a statistical and risk-based approach. Considers any quality, compliance, customer, and business risks.
Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation
Develops tools to communicate complex technical problems and solutions to a variety of audiences within the organization
Proficient in project management, data analysis, root cause analysis, communication, and risk determination
Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies as pertaining to medical devices.
Must Have Requirements:
Bachelor's degree in Engineering
College Grads (encouraged to apply



  • Irvine, United States First Tek Full time

    Develops, modifies, applies, and maintains quality standards and evaluation methods for products and processes. Provides moderately complex statistical information for quality improvement by determining and applying testing methods and criteria. Coordinates and guides technical evaluations, analysis, and related data acquisition processes to ensure division...


  • Irvine, California, United States Kia America Full time

    Job Title: Service Quality SpecialistJob Summary: We are seeking a highly skilled Service Quality Specialist to join our team at Kia America. The successful candidate will play a key role in ensuring the highest level of quality in our products, working closely with various engineering groups in North America and Korea.Main Responsibilities:Platform...

  • Quality Engineer

    2 months ago


    Irvine, United States Entegee Full time

    Job DescriptionJob DescriptionSummary: Seeking a Quality Engineer to lead the development and optimization of manufacturing processes, execute complex tests, and address quality and compliance issues within the medical device industry.Requirements:Bachelor's degree in engineering.5-7 years of experience in a related field.Proficiency with engineering...


  • Irvine, United States Edwards Lifesciences Full time

    Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart...


  • Irvine, United States ShiftCode Analytics Full time

    Title: Senior Quality Engineer (Design) Location: Irvine, CA On-site Duration: 6 months+ Visa: Any Visas(except h1b and CPT) Interview: Phone/Zoom Key Role Responsibilities: • Focus on activities supporting design control, design verification/validation, FMEA/risk management, specification development, statistical reliability, critical to...

  • THV Quality Engineer

    2 months ago


    Irvine, United States Entegee Full time

    Job DescriptionJob DescriptionSummary: Seeking a THV Quality Engineer to investigate product quality issues, perform device testing, and manage complaint investigations in the medical device industry.Requirements:Bachelor's degree in engineering with 0 - 2 years of related work experience.Experience with medical device complaint investigations, including...


  • Irvine, United States SysMind Tech Full time

    Role name: Engineer Role Description: Quality Management Systems, FDA, Presentation, Strong communication skills, ISO 13485, Medical Device, Regulatory Standards, Quality Compliance, CAPA / NC Competencies: EIS : Medical Device & Regulations Experience (Years): 6-8 Essential Skills: A minimum of Technical/Engineering Degree with 8+ years of related...


  • Irvine, California, United States Glidewell Full time

    Job Title: Senior Quality Assurance EngineerGlidewell Laboratories is seeking a highly skilled Senior Quality Assurance Engineer to join our team. As a key member of our quality team, you will be responsible for leading the implementation of our Software Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485...


  • Irvine, United States Q CELLS USA Corp. Full time

    Description POSITION DESCRIPTION: EnFin is seeking a highly skilled and motivated Quality Engineering Manager to lead our software quality assurance and testing efforts. The successful candidate will be responsible for defining testing strategies, ensuring high-quality software releases, and driving process improvements. The role requires strong leadership,...

  • Software Engineer

    3 days ago


    Irvine, California, United States Insight Global Full time

    We are looking for a skilled Software Engineer to join our team at {company}. The successful candidate will be responsible for designing, developing, and maintaining our software applications.Main Responsibilities:Design and implement software applications using programming languages such as Java and PythonCollaborate with cross-functional teams to identify...

  • Quality Engineer

    1 week ago


    Irvine, United States Bio-Rad Laboratories Full time

    As part of the global PSUR Reporting Team, the candidate will be facilitating business data collection and reporting efforts and generating periodic product PSUR / post market surveillance reports. This includes regular interactions with area subject matter experts to ensure data is collected, documented, and analyzed in a timely and accurate manner. The...

  • Quality Engineer

    2 weeks ago


    Irvine, United States Bio-Rad Laboratories Full time

    As part of the global PSUR Reporting Team, the candidate will be facilitating business data collection and reporting efforts and generating periodic product PSUR / post market surveillance reports. This includes regular interactions with area subject matter experts to ensure data is collected, documented, and analyzed in a timely and accurate manner. The...


  • Irvine, United States Edwards Lifesciences Full time

    **Please note that this is an "onsite" role, and the successful candidate will be expected to work from our corporate Irvine, CA campus. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative,...


  • Irvine, United States Taco Bell Full time

    Who is Taco Bell? Taco Bell was born and raised in California and has been around since 1962. We went from selling everyone's favorite Crunchy Tacos on the West Coast to a global brand with 8,200+ restaurants, 350 franchise organizations, that serve 42+ million fans each week around the globe. We're not only the largest Mexican-inspired quick service brand...


  • IRVINE, United States Supernal Full time

    Rise above. Are you ready to take human possibility to a new dimension with us? Supernal is an Advanced Air Mobility (AAM) company that’s developing an electric vertical take-off and landing (eVTOL) vehicle and the ground-to-air ecosystem to support the emerging industry. By creating a sustainable, integrated, and human-centered ecosystem, we are committed...


  • Irvine, United States Glidewell Full time

    Description Position at Prismatik Essential Functions : Leads the ongoing implementation of Software Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls, through the integration of internal and external/medical device industry best practices. Responsible for the administration of...


  • Irvine, United States Yorke Engineering, LLC Full time

    Join Yorke Engineering, LLC, an Environmental Consulting leader in California that implements Environmental Engineering and Compliance solutions for our clients throughout California. Our mission is to solve environmental compliance problems for industrial and governmental/infrastructure facilities. We are a growing and dynamic organization of highly...


  • Irvine, United States Yorke Engineering, LLC Full time

    Join Yorke Engineering, LLC, an Environmental Consulting leader in California that implements Environmental Engineering and Compliance solutions for our clients throughout California. Our mission is to solve environmental compliance problems for industrial and governmental/infrastructure facilities. We are a growing and dynamic organization of highly...


  • Irvine, United States Edwards Lifesciences Full time

    Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart...


  • Irvine, California, United States Kentucky Personnel Cabinet Full time

    Job DescriptionJob Title: Senior Software Engineer - Python DevelopmentJob SummaryWe are seeking a highly skilled and experienced Senior Software Engineer to join our team. As a key member of our development team, you will be responsible for designing, developing, and maintaining complex software systems using Python. If you have a passion for coding, a...