THV Quality Engineer

2 months ago


Irvine, United States Entegee Full time
Job DescriptionJob Description

Summary: 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 CAPAs, NCRs, and Root-Cause Analysis.

  • Proficiency with the Microsoft Office suite.

  • Experience performing functional, physical, and visual testing of medical equipment in a laboratory setting.

  • Basic understanding of statistical techniques.

  • Solid knowledge of engineering principles, theories, and concepts.

  • Familiarity with Quality systems and adherence to their regulations.

Preferred Skills:

  • Experience in the medical device field (cardiovascular, endovascular or critical care/surgical products).

  • Good documentation skills along with strong communication and interpersonal relationship abilities.

  • Previous experience working with lab/industrial equipment.

Responsibilities:

  • Investigate complex product quality and compliance issues from the field; analyze results to determine root causes/probable causes.

  • Perform hands-on device investigation using various test equipment to determine root cause.

  • Assess events against risk documentation for clinical/compliance risks; escalate as necessary.

  • Participate in escalation tasks such as Project Risk Assessments (PRA) and Corrective/Preventive Actions (CAPAs), SCARs based on investigation findings.

  • Report key complaint metrics by device category; collaborate with manufacturing teams to resolve production/device related issues.

 

 Pay: 35-40

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.

 

 



Pay Details: $30.00 to $40.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.Company DescriptionSpecializes in custom automation projects, they are a major player in the world of controls and robotic solutions around the world. My client will expand anyone resume and build them to be a top performing controls engineer.Company DescriptionSpecializes in custom automation projects, they are a major player in the world of controls and robotic solutions around the world. My client will expand anyone resume and build them to be a top performing controls engineer.

  • 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 Entegee Full time

    Job SummaryEntegee, a leading provider of custom automation solutions, seeks an experienced THV Quality Engineer to investigate product quality issues and manage complaint investigations in the medical device industry.Our ideal candidate has a strong background in engineering with excellent analytical skills. The role involves hands-on device investigation...


  • 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 Edwards Lifesciences Full time

    Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. 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 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 Edwards Lifesciences Full time

    At Edwards Lifesciences, we are transforming patient care with innovative medical devices. Our Transcatheter Heart Valve (THV) business unit is a key player in this journey.About the RoleWe are seeking a highly skilled Senior Quality Assurance Engineer to join our team in Irvine, CA. As a Senior Quality Assurance Engineer, you will play a critical role in...


  • Irvine, United States Edwards Lifesciences Full time

    Senior Principal, Biostatistician- Transcatheter Heart Valve 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...

  • 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...

  • 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...


  • 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...


  • 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, 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,...

  • 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...

  • 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, California, United States Cordis Full time

    Job OverviewCordis, a leading innovator in medical devices, seeks a seasoned Senior Quality Engineer to drive quality excellence in our medical device development operations. As a key member of our operations team, you will play a crucial role in ensuring the highest quality standards are met throughout the manufacturing process.About the RoleThis is a...


  • Irvine, California, United States Turion Space Full time

    Job DescriptionAs a Software Test Engineer at Turion Space, you will be responsible for implementing testing procedures on software programs. Your tasks will include developing testing procedures, conducting software testing, and creating reports on the software's performance.Key ResponsibilitiesTest Planning: Develop detailed test plans, test cases, and...


  • 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 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, 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...