Specialist, Quality Compliance

Edwards Lifesciences • Indianapolis, IN

3d

About The Position

The Specialist, Quality Compliance supports quality compliance activities and business outcomes for Edwards’ Transcatheter Mitral and Tricuspid Therapies business unit. The role applies professional expertise and judgment to evaluate customer complaint information, determine whether events qualify as complaints, and escalate matters as appropriate. It works with customers and internal teams throughout complaint investigations and resolution, and may assist with auditing complaint files.

The position evaluates complaints for Medical Device Reporting, prepares and submits reports to the FDA, summarizes investigation findings, reviews relevant product and labeling information, and prepares final customer correspondence. It also identifies process problems and leads projects to improve processes, procedures, or practices.

Requirements

• At least 3 years of complaint-handling experience or equivalent work experience based on Edwards criteria.
• Experience working in a medical device, healthcare, or related environment is required.
• Demonstrated problem-solving, critical-thinking, and investigative skills.
• Excellent written and verbal communication and interpersonal relationship skills.
• Ability to build stable and productive internal and external working relationships.
• Full knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance.
• Good knowledge of medical terminology and human anatomy.
• Full knowledge of Medical Device Reporting regulations and regulatory reporting regulations.
• Good knowledge of Good Documentation Practices (GDP) as they relate 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.
• Ability to work in a team environment, including inter-departmental teams, and represent the department on specific projects.
• Ability to operate general office machinery.
• Adhere to company rules and requirements, including pandemic protocols and Environmental Health & Safety rules, and take adequate control measures to prevent injuries and pollution and protect the environment within their span of influence or control.

Nice To Haves

• Proven expertise in the MS Office Suite.
• Experience in medical devices—particularly cardiovascular, endovascular, or other critical-care or surgical products—or in healthcare or a related environment; the posting also identifies this experience as required.

Responsibilities

• Assess complaint information, determine whether events qualify as complaints, and escalate as appropriate.
• Manage customer relationships and expectations during complaint investigations and resolution.
• Research and obtain information and input from Product Safety, Engineering, and other departments or business units for complaint investigations, challenging input as appropriate.
• Identify problems and lead projects to improve processes, procedures, or practices; recommend solutions and devise new approaches where needed.
• Evaluate complaints for Medical Device Reporting (MDR) and prepare and submit MDR reports to the FDA.
• Summarize findings, including review of the investigation, product analysis, imaging, instructions for use, and other relevant labeling or training materials, and formulate conclusions.
• Prepare and submit final customer correspondence.
• Perform other duties assigned by Leadership; may assist in auditing complaint files.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed