New · posted Nov 12
Edwards Lifesciences · Medical Devices
Quality Compliance Specialist
- Irvine, CA
- On-site
- Full-time
- Associate & Specialist
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.
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. In this role, you will apply professional expertise and judgment to support quality compliance activities and business outcomes.
What you need
What you'll need (Required)
• Bachelor's Degree in related field, 3 years’ experience complaint handling or equivalent work experience based on Edwards criteria
What else we look for (Preferred)nice to have
• Proven expertise in MS Office Suite and ability to operate general office machinery
• Medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment or equivalent work experience based on Edwards criteria preferred.
• Excellent written and verbal communication skills and interpersonal relationship skills
• Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment required
• Demonstrated problem-solving , critical thinking, and investigative skills Ability to build stable working internal/external relationships
• Full knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance
• Good knowledge of medical terms and human anatomy
• Full knowledge of Medical Device Reporting regulations, and regulatory reporting regulations
• Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing
• Ability to manage confidential information with discretion
• Attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including inter-departmental teams and representing the department on specific projects
• Ability to build productive internal/external working relationships
• 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.
The base pay range for this position is $68,000 to $96,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., geographic location, 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
• Assess complaint information provided; evaluate each event for determination if it qualifies as a complaint; escalate as appropriate
• Manage customer relationships and expectations during the course of complaint investigation and resolution process
• Research, seek information and input, and challenge as appropriate, from Product Safety, Engineering and other departments/business units for complaint investigations
• Identify problems and lead projects to improve processes, procedures, and/or practices; recommend solutions, including devising new approaches to problems encountered
• Evaluate complaints for Medical Device Reporting (MDR); prepare and submit MDR reports to FDA
• Summarize findings, including a review of the investigation, product analysis, imaging review, instructions for use (IFU), and any other relevant labeling and/or training materials, and formulate conclusions
• Prepare and submit final customer correspondence
• Other duties assigned by Leadership (May assist in auditing complaint files)
Pay and benefits
$68,000 – $96,000 a year
Employer providedCompetitive salary
Performance-based incentives
Wide variety of benefits programs
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 · November 12, 2026
Salary intelligence
How the pay compares
This role's midpoint is 3% below the US median for Complaints & Post-Market Quality roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US11 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $68,000 | — | $96,000 |
| All US (middle half) | $82,500 | $84,500 | $104,500 |
This role: Edwards Lifesciences's own published range. Comparisons: the base pay employers published on open Complaints & Post-Market Quality roles at the same level on Regulatory Jobs, November 12, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Complaints & Post-Market Quality
The general path across 29 open Complaints & Post-Market Quality roles on Regulatory Jobs, with the titles they carry most. Not Edwards Lifesciences's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 28 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Investigations and CAPA9
- Collaboration and leadership6
- GMP and compliance4
- Documentation and SOPs4
- Regulatory submissions2
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Complaints & Post-Market Quality work in medical devices, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctionsNamed in the posting
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilanceNamed in the posting
- FDA21 CFR Part 806(official source, opens in a new tab)Reports of medical device corrections and removals
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485
- 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
- EUMDCG guidance(official source, opens in a new tab)The Medical Device Coordination Group's endorsed guidance on applying the MDR and IVDR
- FDA21 CFR Part 7(official source, opens in a new tab)FDA enforcement policy, including product recalls
- FDA21 CFR Part 830 (UDI)(official source, opens in a new tab)Unique device identification and the GUDID database
- EUEU IVDR (Regulation 2017/746)(official source, opens in a new tab)The EU In Vitro Diagnostic Medical Devices Regulation
- IMDRFIMDRF(official source, opens in a new tab)International Medical Device Regulators Forum guidance, including software as a medical device
- Health CanadaCanada Medical Devices Regulations(official source, opens in a new tab)Health Canada's licensing and quality requirements for medical devices (SOR/98-282)
- MHRAUK MHRA(official source, opens in a new tab)The UK regulator of medicines and medical devices, including UKCA marking
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
Company hiring pulse
Edwards Lifesciences on Regulatory Jobs
- 31
- Open roles
- 31
- Distinct roles
- 7
- Locations
By discipline
- Quality18 58%
- Clinical7 23%
- Regulatory6 19%
By level
- Senior & Principal20 65%
- Associate & Specialist6 19%
- Director3 10%
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Quality Compliance Specialist at Edwards Lifesciences
Open until filled. $68K–$96K a year, employer provided.