At Edwards Lifesciences, we’re committed to operating with honesty, openness, and fairness. Compliance with the highest levels of integrity is vital to building and maintaining the many trusted relationships that sustain our reputation and credibility. Your dedication to operational excellence will ensure employee business practices meet Edwards’ high ethical standards and continue to enable us to transform patient lives around the world.

The role:

International Quality Compliance Specialist focused on TMTT Business Unit. The role is responsible for post market surveillance and complaint handling activities in compliance with ISO13485, FDA, and other global regulatory requirements, including investigation of events for reportability and submission to Competent Authorities around the globe.

Key responsibilities include managing complex complaint investigations, maintaining effective communication with stakeholders (field people, quality partners, business colleagues, etc.), and ensuring timely and accurate reporting—particularly to the FDA, as the team has recently assumed this responsibility. 

Attention to detail, team spirit, communication skills, stakeholders management, and fluency in English (C1) are essential for success in this role.

The selected candidate will work closely with cross-functional teams in Valencia and the US, contributing to a collaborative and high-performing environment. The role also involves supporting continuous improvement initiatives and ensuring adherence to internal quality and compliance standards.

How you will make an Impact:

Investigate complaints that include moderately complex scenarios:

Evaluate event to determine if it qualifies as a complaint

Manage customer relationship and expectations during course of complaint investigation and resolution process

Assess complaint information provided and conduct additional investigation as needed and escalate as appropriate

Seek information and input, and challenge as appropriate, from Product Safety, Engineering and other departments/business units for complaint investigations

Evaluate complaints for Medical Device Reporting to competent authorities

Prepare and submit reports to Competent Authorities, after review by more senior team member after review by more senior team member

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, after review by more senior team member

May plan agenda for and run meetings to discuss complaint issues with affected functions (e.g., Manufacturing, Quality Assurance, Suppliers, etc.) to identify assignable root cause, resolve open action items, and gather additional technical information to resolve complaint

Identify problems and may lead projects to improve processes, procedures, and/or practices, and recommend solutions, including devising new approaches to problems encountered

Other incidental duties; May assist in auditing complaint files and may develop reports; May assist manager with specially assigned tasks

What you will need:

Bachelor's Degree in related field , 3 years experience of complaint handling-similar experience

Other: Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment

What else we look for:

Proven expertise in MS Office Suite and ability to operate general office machinery

Excellent written and verbal communication skills and interpersonal relationship skills

Demonstrated problem-solving, critical thinking, and investigative skills

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 Vigilance 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