Senior Quality Assurance Engineer

4 weeks ago


Irvine, California, United States Entegee Full time
Job Overview

We are seeking a skilled Senior Quality Assurance Engineer to join our team at Entegee, a leader in custom automation projects and robotic solutions. In this role, you will play a crucial part in ensuring the quality and compliance of our medical devices.

Salary Range

The estimated annual salary for this position is $71,600 - $83,200, based on an hourly rate of $35-$40.

Job 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.
Requirements and Qualifications
  • 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.
Benefits

Our company offers a comprehensive benefits package, including:

  • Medical, dental, vision insurance.
  • Term life insurance.
  • Short-term disability insurance.
  • Addition voluntary benefits.
  • Commuter benefits.
  • A 401K plan.
Company Description

Entegee specializes in custom automation projects and is a major player in the world of controls and robotic solutions around the world. We pride ourselves on helping our associates grow and expand their resumes to become top-performing professionals.



  • Irvine, California, United States SysMind Tech Full time

    Job Overview SysMind Tech is seeking a highly experienced Senior Quality Assurance Engineer to lead our Supplier Quality Management (SQM) function globally. The ideal candidate will have a minimum of 8+ years of related experience in the Medical Device domain, with expertise in regulatory compliance requirements, quality system regulations, and ISO...


  • Irvine, California, United States B. Braun Medical Inc Full time

    OverviewB. Braun Medical Inc., a leading manufacturer of innovative medical products, is seeking a highly skilled QA Engineer II to join our team in Irvine, CA.This role offers an exciting opportunity to provide quality engineering support to production, ensuring compliance with company policies and procedures. The ideal candidate will have 4-6 years of...


  • Irvine, California, United States The Judge Group Full time

    About the JobAs a Senior Quality Assurance Specialist at The Judge Group, you will play a crucial role in ensuring the quality and continuity of our manufacturing processes.Job SummaryWe are seeking a highly skilled and experienced Senior Quality Assurance Specialist to join our team. In this role, you will be responsible for developing and executing plans...


  • Irvine, California, United States B. Braun Medical Inc Full time

    About B. Braun Medical Inc.">OverviewB. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to...


  • Irvine, California, United States Edwards Lifesciences Full time

    Job OverviewAs a Senior Supplier Quality Engineer at Edwards Lifesciences, you will play a critical role in ensuring the quality and integrity of our medical device components. We are seeking an experienced professional to lead successful part qualification efforts with external suppliers, supporting product development and commercial launch timelines.


  • Irvine, California, United States Turion Space Full time

    Job Title: Software Engineer for Quality AssuranceEstimated Salary: $120,000 - $180,000 per yearTurion Space is seeking a highly skilled Software Engineer for Quality Assurance to join our team. As a key member of our software development process, you will be responsible for implementing testing procedures on software programs.Key Responsibilities:Develop...


  • Irvine, California, United States Hexagon Manufacturing Intelligence Full time

    Hexagon Manufacturing Intelligence Job DescriptionWe are seeking a Quality Assurance Engineer - Metrology to join our team at Hexagon Manufacturing Intelligence. As a key member of our quality assurance team, you will ensure that our metrology inspection solutions meet the highest standards of quality and accuracy.About the JobIn this role, you will be...


  • Irvine, California, United States SysMind Tech Full time

    At SysMind Tech, we are seeking a Quality Assurance Engineer to join our team. As a key member of our organization, you will play a critical role in ensuring the quality of our products and services.The estimated salary for this position is $120,000 - $150,000 per year, depending on experience.The Job Description:Provide timely business support for the...


  • Irvine, California, United States Futran Tech Solutions Pvt. Ltd. Full time

    We are seeking a skilled Senior SW Quality Assurance Specialist to join our team at Futran Tech Solutions Pvt. Ltd. As a System Validation and Verification Professional, you will be responsible for ensuring the quality of our software products by planning and executing testing procedures.The ideal candidate will have a strong background in software testing,...

  • Automation Engineer

    2 weeks ago


    Irvine, California, United States Amazon Full time

    Key ResponsibilitiesWe are seeking a skilled Quality Assurance Engineer to drive the customer experience for grocery at Amazon scale across some of the most well-known worldwide brands. As part of this role, you will define and execute comprehensive test strategies for medium to large projects with an emphasis on automated execution. Your strong analytical...


  • Irvine, California, United States Amazon Full time

    Company OverviewAt Amazon, we are re-inventing the way customers complete their grocery missions. We're looking for a talented Quality Assurance Engineer to join our team and drive customer experience for grocery across some of the most well-known worldwide brands.


  • Irvine, California, United States Amazon Full time

    We're seeking an experienced Quality Assurance Engineer to own software quality that is critical to customer experience at Amazon scale. You will be responsible for defining and executing comprehensive test strategies for medium to large projects with an emphasis on automated execution.The ideal candidate will possess deep expertise in QA methodologies while...


  • Irvine, California, United States Turion Space Full time

    Job OverviewTurion Space is seeking a skilled Software Quality Assurance Engineer to join our team. This role involves implementing test procedures on software, collaborating with cross-disciplinary teams to ensure that flight software meets performance, reliability, and mission-specific requirements.Key Responsibilities:Develop Comprehensive Test Plans:...


  • Irvine, California, United States Entegee Full time

    At Entegee, we are currently seeking a skilled Quality Assurance Specialist to join our team. As a key member of our quality assurance department, you will be responsible for investigating moderately complex manufacturing product quality and compliance issues, analyzing results, and developing reports to ensure compliance and optimization of manufacturing...

  • THV Quality Engineer

    4 weeks ago


    Irvine, California, United States Entegee Full time

    Job DescriptionEntegee is seeking a THV Quality Engineer to lead quality assurance activities for our medical device products.Key ResponsibilitiesInvestigate product quality and compliance issues in the field, analyze results to identify root causes.Perform hands-on device testing using various test equipment to determine root causes.Assess events against...


  • Irvine, California, United States Terran Orbital Full time

    Satellite Industry ExpertiseTerran Orbital provides end-to-end satellite solutions by combining satellite design, production, launch planning, mission operations, and on-orbit support. As a Senior Quality Engineer, you will be responsible for developing and implementing quality systems that meet the highest industry standards.Main Responsibilities:Plan and...


  • Irvine, California, United States B. Braun Medical Inc Full time

    OverviewB. Braun Medical Inc., a leading provider of innovative medical products and services, is seeking a highly skilled Quality Assurance Specialist to join its team in Irvine, CA.The ideal candidate will have a strong background in quality engineering and experience working with cross-functional teams to ensure compliance with regulatory standards.Job...


  • 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, California, United States Turion Space Full time

    Job OverviewTurion Space is seeking an exceptional Software Quality Assurance Engineer to join our team. In this role, you will be responsible for ensuring the quality and reliability of our software applications. As a key member of our team, you will work closely with software developers, product managers, and other stakeholders to ensure that our software...


  • Irvine, California, United States Actalent Full time

    Job OverviewActalent is a global leader in engineering and sciences services and talent solutions, seeking an experienced Quality Assurance Specialist to join our team. This contract position involves ensuring compliance with regulatory standards and cGMP regulations.