New · posted Oct 20
Edwards Lifesciences · Medical Devices
Supplier Quality Engineer II, Component New Product Development
- Irvine, CA
- On-site
- Full-time
- Senior & Principal
Open until filled
The role
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 Surgical 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 parts qualification efforts with external suppliers to support product development and commercial launch timelines. Will also be responsible for resolving manufacturing quality issues, supporting CAPA/non-conformances, validating and improving processes, managing risk documentation, and driving Lean/Six Sigma improvements while ensuring regulatory and quality-system compliance. This role will work on-site in a very fast-paced and dynamic environment where being proactive and taking initiative is paramount to success.
What you need
What you’ll need (Required)
- Bachelor’s degree in engineering or scientific field with at least 2 years of experience with either supplier quality, quality, manufacturing, 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 15% - 20%.
- Must be willing and able to work onsite 100%.
What else we look for (Preferred)nice to have
- Engineering degree
- Medical Device, Aerospace, or Automotive industry experience.
- Experience and/or proficient knowledge of Design Controls and test method development/validations.
- Experience with statistical techniques and tools such 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 applied through CAPAs.
- Knowledge of GD&T and ability to read and interpret drawings.
- Good understanding of process validations (IQ, OQ, PQ)
- Good understanding of manufacturing processes (i.e., injection molding, extrusion, machining, etc.).
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 $87,000 - $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.
What you'll do
How you will make an impact
- 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.
- Manage component and supplier qualification activities from initiation to closure.
- Supports completion of Design File requirements applicable to supplied components, subassemblies, devices, and services.
- Create test method procedures and provide training. Provide engineering support to Receiving Inspection on component test methods and investigations.
- Conduct on-site supplier audits.
- Manage supplier-related non-conformances.
- Manage supplier corrective action requests from initiation to closure.
- Report on supplier part qualification status at recurring cross-functional project meetings
Pay and benefits
$87,000 – $123,000 a year
Employer providedCompetitive salaries
Performance-based incentives
Where you'll work
Irvine, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Irvine, CAEqual opportunity, accessibility and legal noticesEdwards Lifesciences's statements, word for word
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Job intelligence
The context around this role
Live data · October 20, 2026
Salary intelligence
How the pay compares
This role's midpoint is 13% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in California89 roles publishing pay
Senior & Principal roles in the US302 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $87,000 | — | $123,000 |
| California (middle half) | $116,000 | $135,000 | $158,500 |
| All US (middle half) | $102,625 | $120,250 | $137,500 |
This role: Edwards Lifesciences's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 20, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 895 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Edwards Lifesciences's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 24 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk8
- Validation and qualification7
- GMP and compliance4
- Investigations and CAPA4
- Collaboration and leadership4
- Lab testing and methods3
- Documentation and SOPs3
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Edwards Lifesciences on Regulatory Jobs
- 28
- Open roles
- 27
- Distinct roles
- 4
- Locations
By discipline
- Quality19 68%
- Regulatory8 29%
- Compliance & Safety1 4%
By level
- Senior & Principal16 57%
- Associate & Specialist8 29%
- Director2 7%
More roles at Edwards Lifesciences
- View role
Principal Engineer, NPD-Quality
Irvine, CASenior & PrincipalMedical Devices$121K–$171K
- View role
Complaints Quality Engineer II - PMS
Irvine, CAAssociate & SpecialistMedical Devices$87K–$123K
- View role
Specialist, Quality Compliance
Indianapolis, INAssociate & SpecialistMedical DevicesSalary not listed
- View role
Sr. Quality Engineer, NPD - IHFM
Irvine, CASenior & PrincipalMedical Devices$108K–$153K
Similar Quality Assurance roles elsewhere
- View role
QA Engineer 2
DexcomSan Diego, CASenior & PrincipalMedical Devices$72K–$119K
- View role
Senior Quality Engineer (Complaint Handling)
AbbottPomona, CASenior & PrincipalMedical Devices$90K–$180K
- View role
Senior Supplier Quality Engineer
iRhythmOrange County, CA · HybridSenior & PrincipalMedical Devices$99K–$129K
- View role
Principal Supplier Quality Engineer
IntegerChaska, MNSenior & PrincipalMedical Devices$144K–$211K
Supplier Quality Engineer II, Component New Product Development at Edwards Lifesciences
Open until filled. $87K–$123K a year, employer provided.