Senior Quality Engineer, Commercial Quality

23 hours ago


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 Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

The Senior Quality Engineer, Commercial Quality will play a key role in support of Edwards transcatheter aortic valve therapies. This role is responsible for leading and supporting key projects associated with our commercialized THV products. This includes support of product configuration changes, providing design control expertise for manufacturing improvements, leading investigations into field performance issues and support of product labeling and training updates associated with our global therapy expansion.

This role will partner closely with other downstream functions in THV including post-market surveillance, global complaint handling and engineering, marketing, regulatory, and the sustaining R&D and supply chain teams. Additionally, this role will partner with upstream product development functions to transfer product design knowledge to post-market teams and to provide a feedback loop for THV field performance data.

How you will make an impact

  • Provide Quality Engineering input to THV commercialized product projects including application of design control and risk management

  • Be a subject matter expert on field performance of THV devices and the design features associated with key performance metrics

  • Adaptable to broad scope of projects including material changes, manufacturing improvements, packaging and labeling changes, use instruction and usability changes.

  • Excellent technical writing and presentation skills to support internal and external communication into field performance investigations

  • Build partnerships with key cross functional stakeholders

  • Stay current with Edwards THV operations and market trends

  • Lead or support investigations including CAPAs resulting from design or product use root causes of commercialized products

  • Lead or support Product Risk Assessments

  • Support Edwards THV global expansion through Quality Engineering support for geographic specific changes

  • Support sustaining engineering projects led by sustaining R&D and Global Supply Chain for commercialized THV products

  • Use Green Belt and Black Belt methodologies to support investigations into field performance issues

  • Support for internal and external audits of the THV business

  • Maintain expertise in applicable global regulations affecting THV Commercial Quality including 21 CFR 820, ISO 13485 and EU MDR

  • Ability to travel up to 10%

What you'll need ( Required Qualifications):

  • Bachelor's Degree required in an engineering or scientific field, plus (4) years of experience in quality engineering; OR Master’s Degree in engineering or scientific field, with (3) years of experience in quality engineering

  • Lifesciences industry experience (i.e. medical device, pharma, or biotech)

  • Experience with design controls, design verification & validation, or design test method development

  • Demonstrated experience reviewing and updating risk management related documents

  • Experience utilizing statistical techniques to support design decisions and product acceptance testing

What else we look for ( Preferred Qualifications):

  • Master's Degree in an engineering, scientific or a related discipline

  • Medical device industry experience highly preferred.

  • Experience in catheter-based therapies preferred.

  • Design control and design change experience for product improvements

  • Experience with sustaining activities for commercialized products

  • Experience in post market investigations, complaint investigations, CAPA investigation, development or manufacturing of transcatheter based therapies

  • Strong experience in quality engineering, R&D or manufacturing engineering

  • Design for Six Sigma or Lean Six Sigma Certification (Green belt or black belt)

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $103,000 to $146,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.



  • 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 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

    Please note that this is an "onsite" role, and the successful candidate will be expected to work from our corporate Irvine, CA campus.** Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest...

  • 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 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 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...

  • 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...

  • 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 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 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 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 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 OrthAlign Full time

    OrthAlign, Inc. , a Smart Technologies, growing medical device company, has an immediate opening for a Director of Product Quality. The Director of Product Quality plays a pivotal role in overseeing and implementing quality control processes to ensure the delivery of high-quality products. This position requires a strategic mindset to establish quality...


  • Irvine, California, United States Jobot Full time

    Opportunity for Experienced Sr. EstimatorsWe are seeking a highly skilled and experienced Sr. Estimator to join our team in Irvine, CA. The successful candidate will play a critical role in delivering high-quality commercial construction projects on schedule and within budget.About the JobThe ideal candidate will have at least 5 years of experience in...


  • 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 Actalent Full time

    Job Title: Quality Assurance Specialist Job Description Process GMP documentation through the electronic document management system ensuring version control, traceable editing, and adequate formatting. Route documents for review and approval, ensuring that approved templates/formats are maintained and consistent across departments. Categorize, scan,...

  • Controls Engineer

    1 month ago


    Irvine, United States ADSYS CONTROLS INC Full time

    Job DescriptionJob DescriptionWe are searching for a Senior Controls/Algorithm Engineer to design and develop software for a distributed control system application. You will work closely with software architects and control system engineers to develop software that meets controls requirements and design specifications. You will also lead projects of small...


  • 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...