ED
EdwardsSenior Engineer, Quality
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Before you apply
Salary$108k – $153k
LocationUSA - California – Irvine
Work modeon-site
Typefull-time
SenioritySenior
Experience3+ yrs
DepartmentQuality
Company size10,000+ people
First seenSep 27, 2026 · 1mo ago
Verified live3d ago
At a glanceSummarised by Seekless from the posting.
Investigate complex manufacturing product quality and compliance issues
Owning complex quality investigations, leading cross-functional teams
Develop, update, and maintain technical content of risk management files and procedures
Lead technical studies and author technical reports
Apply statistical techniques to determine sample sizes and confidence levels
Optimize manufacturing processes using Six Sigma and Lean
Train, coach, and guide peers and junior employees
Bachelor's degree in Engineering or Scientific field with 4 years relevant experience
Master's degree in Engineering or Scientific field with 3 years of experience
GDP and GMP proficiency in medical device, pharma, or biotech industry
Strong problem-solving, organizational, analytical, and critical-thinking skills
Solid leadership skills and ability to influence change
Understanding of manufacturing, quality, and risk management standards
FDA Quality System Regulation / 21 CFR Part 820, ISO 13485, ISO 14971, and EU MDR awareness
Experience with inspection and measurement tools & equipment (microscope, TAPPI, burst tester, tensile tester)
Nonconformance and CAPA management experience with root cause analysis tools (Five Whys, Fishbone, Flow Chart)
Working knowledge of statistical data analysis and SPC (Minitab proficiency)
Process / Equipment qualification & validation experience (Test method validation, IQ/OQ/PQ, Tool and fixture IQ)
Expertise in MS Office Suite and experience with digital productivity tools and AI-enabled applications
Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities
Skills
MS Office Suite
Minitab
microscope
TAPPI
burst tester
tensile tester
Benefits
Health insurance
401(k)
Unlimited PTO
Remote stipend
About the company
Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Senior Engineer, Quality position is a unique career opportunity that could be your next step towards an exciting future.
About 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.
As a Manufacturing Sustaining Senior Quality Engineer supporting 1st shift Irvine Implant Manufacturing operations, this role applies quality engineering principles to maintain compliant manufacturing processes, resolve complex product quality and compliance issues, support risk management activities, and drive continuous improvement in a regulated medical device environment.
How you’ll make an impact:
•
Investigate complex manufacturing product quality and compliance issues reported internally and/or from the field, analyze results, determine root causes, and initiate and review reports (e.g., Non-Conformances, CAPA, Audit resolutions).
•
Exercise independent judgment in owning complex quality investigations, leading cross-functional teams to align on root cause, risk impact, containment, and corrective actions, and driving systemic actions that prevent recurrence.
•
Develop, update, and maintain the technical content of risk management files and procedures.
•
Lead technical studies and author technical reports. Apply statistical techniques to determine appropriate sample sizes and confidence levels.
•
Optimize complex manufacturing processes using quality engineering methods (e.g., Six Sigma and Lean) to drive design for manufacturing and continuous process improvement.
•
Train, coach, and guide peers and junior employees.
What you’ll need (Required):
•
Bachelor’s degree in Engineering or Scientific field with a minimum of 4 years relevant experience in Quality Engineering, Product & Process Engineering, Quality Systems, or Manufacturing; OR
•
Master’s degree in Engineering or Scientific field with 3 years of experience.
What else we look for (Preferred):
•
GDP and GMP proficiency and experience working in medical device, pharma, or biotech industry.
•
Strong problem-solving, organizational, analytical, strict attention to detail, and critical-thinking skills.
•
Solid leadership skills and the ability to influence change.
•
Understanding of manufacturing, quality, and risk management standards.
•
FDA Quality System Regulation / 21 CFR Part 820, ISO 13485, ISO 14971, and EU MDR awareness.
•
Experience working with inspection and measurement tools & equipment (e.g. microscope, TAPPI, burst tester, tensile tester).
•
Nonconformance and CAPA management experience utilizing investigation tools for root cause analysis (e.g. Five Whys Analysis, Fishbone diagram, Flow Chart/Process Mapping).
•
Working knowledge of statistical data analysis and SPC (Minitab proficiency).
•
Process / Equipment qualification & validation experience (Test method validation, IQ/OQ/PQ, Tool and fixture IQ).
•
Expertise in usage of MS Office Suite and experience using digital productivity tools and AI-enabled applications.
Benefits
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 $108,000 - $153,000 (highly experienced).
Hiring process
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.
Legal
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.