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New · posted Oct 19

Edwards Lifesciences · Medical Devices

Complaints Quality Engineer II - PMS

  • Irvine, CA
  • On-site
  • Full-time
  • Associate & Specialist
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EmploymentFull-time
Deadline

Open until filled

The role

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. 
This Quality Engineer will support, perform, and/or complete assigned complaint investigations that include (but are not limited to) product failure analysis and complaint documentation review (device history record, complaint history, products instructions, risk management, etc.), and prepare technical investigation reports.

What you need

What you'll need (Required Qualifications)

• Bachelor's Degree in Engineering/Scientific field with 2 years of experience in Quality Engineering or Quality Assurance; OR Master’s degree in Engineering or Scientific field with either no experience (or internship experience).
• Experience with root cause analysis or investigations for Complaints, NCRs, and/or CAPAs.

What else we look for (Preferred Qualifications)nice to have

• Experience with medical devices and working under a medical device regulated environment
• Experience in medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment.
• Complaints investigation experience and/or hands-on experience with device investigations
• Demonstrated experience with risk management/risk assessments
• Experience working in lab environment and familiarity with common measurement/test equipment (calipers, micrometers, pressure gages, leak testing, etc.)
• Experience with data analysis and able to generate metrics for trending and review
• Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Basic understanding of statistical techniques
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment
• Knowledge of and adherence to Quality systems
• Must be able to work in a team environment
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

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.

Every employee is essential to Edwards’ success, and we’re ready to help you advance along your career path!

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world.  As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role.  If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.

What you'll do

How you will make an impact

• Investigate complex manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.
• Support external regulatory or competent authority requests with complaint risk and metric analysis as needed.
• Assess reported events against established risk documentation for clinical and compliance risk(s) and escalate to Quality Management and Product Safety as needed.
• Participate in escalation tasks and activities, including Product Risk Assessments (PRA) and Corrective/Preventive action(s) – CAPAs, SCARs, as determination by investigation.
• Identify and report key complaint metrics per device category and collaborate with applicable manufacturing engineering teams to resolve production/device related issues.
• Other incidental duties assigned by Leadership (May assist in Adhoc complaint analysis or metric review).

Pay and benefits

$87,000 – $123,000 a year

Employer provided
How this compares

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.

  • Competitive salaries

  • Performance-based incentives

  • Wide variety of benefits programs for employees and families

Where you'll work

Irvine, CAOn-siteOpen in Maps (opens in a new tab)

More jobs in Irvine, CA
Equal 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 30% above the US median for Quality Assurance roles at this level.

This roleEmployer provided

$87,000 to $123,000 a year

Associate & Specialist roles in California30 roles publishing pay

Middle half $78,125 to $103,625, median $88,750

Associate & Specialist roles in the US172 roles publishing pay

Middle half $59,000 to $93,625, median $80,500
Annual base pay
Annual base payLowMedianHigh
This role$87,000—$123,000
California$78,125$88,750$103,625
All US$59,000$80,500$93,625

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.

  1. This role

    Associate & Specialist

    Often: Quality Engineer · Quality Technician

    $81K median243 open
  2. Next step

    Senior & Principal

    Often: Quality Engineer · Senior Quality Engineer

    $120K median381 open
  3. Later

    Manager

    Often: Manager, Quality Assurance · Quality Manager

    $155K median138 open
  4. Later

    Director

    Often: Director, Quality · Associate Director, Quality Assurance

    $209K median118 open
  5. Later

    VP & Executive

    Often: AVP · Executive Director Quality, Cell & Gene Therapy

    $302K median15 open

Skills DNA

What this role leans on

How many of the posting's 7 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 1 lineLab testing and methods: 1 lineDocumentation and SOPs: 3 linesInvestigations and CAPA: 4 linesQuality systems and risk: 3 linesCollaboration and leadership: 3 linesGMPLab testingDocumentationInvestigationsQuality systemsTeamwork
  • Investigations and CAPA4
  • Documentation and SOPs3
  • Quality systems and risk3
  • Collaboration and leadership3
  • GMP and compliance1
  • Lab testing and methods1

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%
See all 28 Edwards Lifesciences roles

More roles at Edwards Lifesciences

All 28 Edwards Lifesciences roles

Similar Quality Assurance roles elsewhere

Complaints Quality Engineer II - PMS at Edwards Lifesciences

Open until filled. $87K–$123K a year, employer provided.

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