Senior Engineer, Quality

Regulatory Jobs; Irvine (CA); On-site; USD 108,000 - 153,000; Full time

Job summary

Edwards Lifesciences is seeking a Manufacturing Sustaining Senior Quality Engineer to support 1st shift Irvine Implant Manufacturing operations. You will apply quality engineering principles to maintain compliant processes, drive CAPA, and lead improvements in a regulated medical-device environment.

Role emphasizes root-cause analysis, Six Sigma/Lean optimization, and collaboration with multi-disciplinary teams to ensure product quality and patient safety globally.

Qualifications

• Bachelor’s degree in Engineering or Scientific field required.
• Master’s degree in Engineering or Scientific field with 3 years of experience preferred.

Responsibilities

• Investigate complex manufacturing quality and compliance issues; analyze results and initiate corrective actions.
• Lead cross-functional teams to determine root causes, containment, and corrective actions to prevent recurrence.
• Develop and maintain risk management files and procedures; ensure alignment with regulatory standards.

Skills

Quality Engineering

Product & Process Engineering

Quality Systems

Manufacturing

Education

Bachelor's degree in Engineering or Scientific field

Master’s degree in Engineering or Scientific field

Tools

MS Office Suite

Minitab

Job description

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.

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.

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).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

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.

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