Quality Compliance Specialist, Medical Devices

Edwards Lifesciences Gruppe; Indianapolis (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

Edwards Lifesciences seeks a Quality Compliance professional to support complaints handling and regulatory activities within our cardiac devices portfolio. You will engage with product safety, engineering, and other teams to investigate events and ensure accurate reporting.

The role emphasizes cross-functional collaboration, adherence to GDP and regulatory guidelines, and timely communication of findings to stakeholders.

Qualifications

• 3 years’ experience in complaint handling or equivalent.
• Experience with medical devices regulatory environments a plus.
• Excellent written and verbal communication skills.
• Ability to work in a fast-paced environment and manage competing priorities.

Responsibilities

• Assess complaint information and determine if it qualifies as a complaint; escalate as appropriate.
• Manage customer relationships during investigation and resolution processes.
• Research information from Product Safety, Engineering and other units for investigations.
• Identify problems and lead process improvements; devise solutions for encountered issues.
• Evaluate complaints for Medical Device Reporting (MDR) and prepare/submit MDR reports to FDA.
• Summarize findings including investigation, product analysis, labeling and training materials, and draw conclusions.
• Prepare and submit final customer correspondence.
• Perform other duties assigned by Leadership as needed, including supporting internal audits.

Skills

Communication

Interpersonal skills

Problem solving

Critical thinking

Investigative skills

Attention to detail

Teamwork

Regulatory familiarity

Tools

MS Office Suite

Job description

Edwards Lifesciences seeks a Quality Compliance professional to support complaints handling and regulatory activities within our cardiac devices portfolio. You will engage with product safety, engineering, and other teams to investigate events and ensure accurate reporting.

The role emphasizes cross-functional collaboration, adherence to GDP and regulatory guidelines, and timely communication of findings to stakeholders.