New · posted Nov 6
Edwards Lifesciences · Medical Devices
Principal Supplier Quality Engineer, Contract Manufacturing (CMO)
- Remote, US
- Remote
- Full-time
- Senior & Principal
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 throughout a product’s lifecycle. Your work will involve optimizing product development and manufacturing performance to impact patients around the world with pioneering technology.
We are seeking a strategic and highly experienced Principal Supplier Quality Engineer to provide quality oversight for Contract Manufacturing Organizations (CMOs) producing finished medical devices. This senior individual-contributor role will serve as a key technical and relationship leader between Edwards, its CMOs, and internal stakeholders across Quality, Sourcing, Supplier Development, Design Engineering, Operations, and Business Unit teams. The role will establish supplier quality roadmaps, monitor supplier performance and risk, address quality and compliance issues, and ensure suppliers remain accountable for corrective actions and continuous improvement commitments.
This position is eligible to be fully remote within the United States. Travel to suppliers and Edwards’ locations may be required based on business needs.
What you need
What you will need (Required)
- Bachelor's degree in engineering or scientific field with at least 6 years of related experience in Supplier Quality Engineering, Quality Engineering/Management, or Manufacturing Engineering, OR Master’s degree in engineering or scientific field with at least 5 years of related experience in Supplier Quality Engineering, Quality Engineering/Management, or Manufacturing Engineering.
- Highly regulated industry experience.
What else we look for (Preferred)nice to have
- Engineering degree
- Medical Device or Pharma industry experience
- Experience overseeing and managing Suppliers or CMOs, including managing audits, NCRs, SCARs, CAPAs, complaint investigations, post-market quality monitoring and notification of changes with suppliers
- Experience supporting Contract Manufacturing Organizations (CMOs) producing finished medical devices, including accountability for end-to-end product quality and performance
- Experience with electronics, PCBA, or electro-mechanical assemblies
- Manufacturing process controls knowledge and experience (process flow, Lean Manufacturing, FMEA, Control plans, Statistical Process Control,).
- In-depth knowledge of domestic and international regulatory requirements (e.g., FDA, GMPs, and ISO/EN standards)
- Demonstrated project leadership and stakeholder-management skills.
- Project management certification or equivalent project leadership experience.
- Knowledge of DMAIC Six Sigma concepts
- In-depth knowledge of Quality Management Systems and Processes
- Extensive knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering
- ASQ certification / Certified Lead Auditor
- Proven expertise in both Microsoft Office Suite and related systems
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 $121,000 to $171,000 (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
- Provide end-to-end quality oversight for assigned CMOs producing finished medical devices, including products shipped directly from the supplier to distribution.
- Monitor and assess supplier performance through quality metrics, scorecards, complaint trends, audits, and key performance indicators; identify risks and drive timely corrective actions and continuous improvement.
- Lead supplier quality activities including CAPAs, SCARs, nonconformances, complaint investigations, root cause analysis, containment, and effectiveness verification.
- Develop and execute supplier quality roadmaps in partnership with Sourcing, Design Engineering, Operations, and other cross-functional stakeholders to address supplier risks, performance gaps, and strategic priorities.
- Build strong, high-touch relationships with CMOs and hold suppliers accountable for quality, compliance, performance, and improvement commitments.
- Partner with suppliers and internal teams to ensure Edwards design requirements are effectively translated into supplier manufacturing processes, controls, specifications, and test methods.
- Provide Supplier Quality support for new product introduction, design and manufacturing transfer, process validation, early commercialization, and production scale-up activities.
- Analyze supplier quality and manufacturing trends to identify emerging risks and lead improvements using quality engineering tools such as FMEA, control plans, Statistical Process Control, Lean, and structured root cause analysis.
- Support the development and continuous improvement of processes for managing finished-device CMOs, particularly where products move directly to distribution without an Edwards manufacturing touchpoint.
- Other incidental duties.
Pay
$121,000 – $171,000 a year
Employer providedEqual 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 · November 6, 2026
Salary intelligence
How the pay compares
This role's midpoint is 20% above the US median for Supplier Quality roles at this level.
This roleEmployer provided
Senior & Principal roles in California14 roles publishing pay
Senior & Principal roles in the US36 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $121,000 | — | $171,000 |
| California (middle half) | $118,375 | $137,500 | $145,250 |
| All US (middle half) | $110,500 | $121,500 | $137,500 |
This role: Edwards Lifesciences's own published range. Comparisons: the base pay employers published on open Supplier Quality roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Supplier Quality
The general path across 85 open Supplier Quality roles on Regulatory Jobs, with the titles they carry most. Not Edwards Lifesciences's own promotion track.
Career resources on Supplier Quality
Skills DNA
What this role leans on
How many of the posting's 30 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk14
- Collaboration and leadership9
- GMP and compliance5
- Investigations and CAPA4
- Lab testing and methods1
- Validation and qualification1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Supplier Quality work in medical devices, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485Named in the posting
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- ISOISO 2859-1(official source, opens in a new tab)Sampling procedures for inspection by attributes (AQL sampling plans)
- FDAMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program shared by five regulators
- ISOISO 9001(official source, opens in a new tab)Quality management systems requirements
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- ISOISO 10993-1(official source, opens in a new tab)Biological evaluation of medical devices within a risk management process
- ISOISO 11135(official source, opens in a new tab)Ethylene oxide sterilization of health care products
- ISOISO 11137-1(official source, opens in a new tab)Radiation sterilization of health care products
- ISOISO 11607-1(official source, opens in a new tab)Packaging for terminally sterilized medical devices
- ISOISO/IEC 17025(official source, opens in a new tab)Competence of testing and calibration laboratories
- FDA21 CFR Part 806(official source, opens in a new tab)Reports of medical device corrections and removals
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
Company hiring pulse
Edwards Lifesciences on Regulatory Jobs
- 31
- Open roles
- 31
- Distinct roles
- 6
- Locations
By discipline
- Quality19 61%
- Regulatory6 19%
- Clinical6 19%
By level
- Senior & Principal20 65%
- Associate & Specialist5 16%
- Director3 10%
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Principal Supplier Quality Engineer, Contract Manufacturing (CMO) at Edwards Lifesciences
Applications close November 11. $121K–$171K a year, employer provided.