New · posted Oct 19
Edwards Lifesciences · Medical Devices
Specialist, Quality Compliance
- Indianapolis, IN
- On-site
- Full-time
- Associate & Specialist
Open until filled
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)
• 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
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)
Where you'll work
Indianapolis, INOn-siteOpen in Maps (opens in a new tab)
More jobs in Indianapolis, INEqual 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
Associate & Specialist roles in the US172 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $59,000 | $80,500 | $93,625 |
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 889 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Edwards Lifesciences's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 27 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
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
From Regulatory News
Manufacturing and quality coverage for this professionCompany 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%
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Specialist, Quality Compliance at Edwards Lifesciences
Open until filled.