Associate Specialist, Quality Compliance

Edwards Lifesciences; Valencia; On-site; EUR 28,000 - 38,000; Full time

Job summary

Edwards Lifesciences in Valencia, Spain, seeks a Quality Specialist to support medical device complaint handling and regulatory reporting. You will investigate complaints, evaluate events, and manage customer expectations throughout the resolution process.

Strong documentation and communication skills are essential. Required are a related bachelor's degree and 1 year of complaint handling experience within healthcare or medical devices.

Qualifications

• Bachelor's Degree in related field.
• 1 year experience with complaint handling.
• Experience in medical devices or healthcare environment is preferred.

Responsibilities

• Fulfill applicable medical device regulations in the region, ISO13485 and other requirements for designated complaint handling unit.
• Investigate complaints with guidance from higher level team members.
• Evaluate events to determine if they qualify as complaints.
• Manage customer relationships during investigation and resolution.
• Assess provided information and conduct further investigations as needed.
• Prepare and submit reports to competent authorities after review by seniors.
• Summarize findings and formulate conclusions.

Skills

Problem solving

Communication

Attention to detail

GDP knowledge

Regulatory knowledge

Education

Bachelor's degree in related field

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.

How you will make an Impact:

• Fulfill applicable medical device regulations in the region, ISO13485 and other relevant requirements for designated complaint handling unit, and evaluation of events for reportability to applicable regulatory bodies.
• Investigate complaints with the support of higher level team member or manager
• 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 escalated as appropriate
• Evaluate complaints for Medical Device Reporting to competent authorities
• Prepare and submit reports to Competent Authorities, 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
• Other incidental duties; May identify problems with processes, procedures, and/or practices, and recommend solutions, including devising new approaches to problems encountered

What you will need (Required):

• Bachelor's Degree in related field, 1 years experience with complaint handling experience
• Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment

What else we look for (Preferred):

• Good computer skills in MS Office Suite and ability to operate general office machinery
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving and critical thinking skills
• Basic 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 with guidance
• Must be able to work in a team environment, including immediate supervisor and other team members in the section or group
• Ability to build stable 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