Supplier Quality Engineer II, Process Validations & Test Methods

Edwards Lifesciences; Irvine (CA); On-site; USD 87,000 - 123,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA is seeking a Supplier Quality Engineer II to lead part qualification with external suppliers, aligning with R&D and manufacturing teams to support product development and launches.

The role requires hands-on quality engineering in a highly regulated environment, strong collaboration, on-site work, and up to 25% travel to suppliers; you’ll drive process validation, CAPAs, and supplier audits while ensuring compliance.

Qualifications

• Bachelor’s degree in engineering with at least 2 years of experience with either supplier quality, quality, manufacturing, R&D or production engineering activities; OR Master’s degree with no experience (or internship/co-op experience).
• Highly regulated industry experience.
• Must have ability to travel up to 25%.
• Ability to work 100% onsite at our Irvine, CA location. This role is not eligible for remote or hybrid work arrangements.

Responsibilities

• Facilitate/perform gage studies, process capability studies, and supplier process validations related to critical component features based on risks identified in FMEAs.
• Develop and validate test methods, which can encompass creating inspection routines on optical measurement equipment and design and creation of inspection fixtures using SolidWorks.
• Create test method procedures and provide training. Provide engineering support to Receiving Inspection on component test methods and investigations.
• Support component specification development, identification of critical features, development of inspection methods and plans, test method validation, process validations and component capability assessments.
• Support risk management activities, including the development and implementation of FMEAs, process control plans, and quality agreements at suppliers.

Skills

Root cause analysis

Cross-functional collaboration

Quality engineering

Regulatory knowledge

Documentation

Education

Bachelor’s degree in engineering

Master’s degree (with no experience)

Tools

SolidWorks

Gage R&R

Statistical Process Control

Process Capability Studies

Job description

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 standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

The Supplier Quality Engineer II will play a key role on critical projects within the Transcatheter Mitral & Tricuspid Therapies (TMTT) business unit. This position is cross-functional in nature and requires strong collaboration and partnership with R&D, Design Assurance, Operations, Regulatory Affairs, Supplier Development Engineering and Receiving Inspection. The primary focus of the position is leading successful part qualification efforts with external suppliers to support product development and commercial launch timelines. The Supplier Quality Engineer II will work on-site in a very fast-paced and dynamic environment where being proactive and taking initiative are paramount to success.

How you will make an impact:

• Facilitate/perform gage studies, process capability studies, and supplier process validations related to criticalcomponentfeatures based on risksidentifiedin FMEAs.
• Developandvalidatetest methods, which can encompass creating inspection routines on optical measurement equipment and design and creation of inspection fixtures using SolidWorks.
• Create test method proceduresandprovidetraining. Provide engineering support to Receiving Inspection oncomponenttest methodsand investigations.
• Supportcomponentspecification development, identification of critical features, development of inspection methods and plans, test method validation,processvalidationsandcomponentcapability assessments
• Supportsrisk management activities, including the development and implementation of FMEAs, process control plans, and quality agreements at suppliers
• Utilize statistical techniques and six sigma tools to analyze processes and drive continuous improvement activities
• Conduct on-site supplier audits.
• Manage supplier-related non-conformances.
• Manage supplier corrective action requests from initiation to closure.
• Collect and analyze Quality metrics relating to Supplier Quality
• Communicate supplier quality risks to upper management during Management Review andprojectmeetings andidentifysolutions to mitigate risks.
• Support process and system improvement projects as assigned by manager

What you’ll need (Required):

• Bachelor’s degree in engineeringwith at least 2 years of experience witheithersupplier quality,quality,manufacturing,R&Dorproductionengineeringactivities; OR Master’s degree with no experience (or internship/co-opexperience).
• Highly regulated industry experience
• Must have ability to travel up to25%
• Ability to work 100% onsite at our Irvine, CA location. This role is not eligible for remote or hybrid work arrangements

What else we look for (Preferred):

• Engineering degree
• Medical Device, Aerospace, or Automotiveindustry experience.
• Knowledge and understanding of FDA’s 21 CFR Part 820, ISO13485, ISO9001, and other International Regulatory Standards.
• Experience and/orproficientknowledge ofDesign Controlsandtest method development/validations.
• Experience with statisticaltechniques and toolssuch as Gage R&R, Statistical Process Control, or Process Capability Studies.
• Ability to conduct effective root cause analysis; driving non-conformance investigations; and assessment of corrective action strategies and effectiveness as appliedthroughCAPAs.
• Knowledge of GD&T and ability to read and interpret drawings.
• Good understanding of process validations(IQ, OQ, PQ)
• Goodunderstanding of manufacturing processes (i.e., injection molding, extrusion, machining, etc.).
• Good interpersonal skills, with the ability to negotiate and influence change.
• Possess the ability to multi-task, whilemaintaininghigh attention to detail
• Ability to achieve results in cross-functional team environment and build strong relationships with internal and external customers(suppliers)

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 (CA), the base pay range for this position is $87,000 to $123,000 (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.