Specialist, Quality Compliance

Edwards Lifesciences Gruppe; Indiana; Hybrid; USD 65,000 - 100,000; Full time

Job summary

Edwards Lifesciences is seeking a Quality Compliance professional to support complaint handling and regulatory reporting within our Transcatheter Mitral and Tricuspid Therapies (TMTT) unit. You will assess complaints, coordinate investigations, and ensure compliance with MDR and GDP across the product lifecycle.

You will collaborate with Product Safety, Engineering and other departments to drive investigations, implement improvements, and maintain patient safety and regulatory standards in a

Qualifications

• 3 years’ experience in complaint handling or equivalent
• Experience with Medical Device Reporting (MDR) to FDA or equivalent
• Strong written and verbal communication skills
• Understanding of GDP and good documentation practices (GDP)

Responsibilities

• Assess complaint information and determine if it qualifies as a complaint; escalate as needed
• Manage customer relationships during investigation and resolution
• Coordinate input from Product Safety, Engineering and other units for investigations
• Identify problems and lead process improvement initiatives
• Evaluate complaints for MDR and prepare submissions to FDA
• Summarize investigation findings, product analysis, IFU, labeling and training materials
• Prepare and submit final customer communications
• Support audit activities and other duties as assigned by Leadership

Skills

Complaint handling

MS Office Suite

Medical device

Communications skills

Regulatory knowledge

Tools

GDP knowledge

Job description

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.

How you will make an impact:

• Assess complaint information provided; evaluate each event for determination if it qualifies as a complaint; escape 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)

What you’ll need (Required):

• 3 years’ experience complaint handling or equivalent work experience based on Edwards criteria

What else we look for (Preferred):

• 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

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

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world‑class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient‑focused culture to deliver life‑changing innovations to those who need them most.