Associate Specialist, Quality Compliance

hace 2 semanas

Valencia, España Edwards Lifesciences A tiempo completo

Associate Specialist, Quality Compliance Type Full time
Location Job reference Req-37170
Posted for 2 days ago
Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Associate Specialist, Quality Compliance position is a unique career opportunity that could be your next step towards an exciting future.
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.
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.

How You'll Make an Impact:
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 escalate 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'll Need (Required):
Bachelor's Degree in related field, 1 year experience complaint handling-similar experience Required
Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment Preferred

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
Moderate knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance
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
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)
What is it like to work at Edwards Lifesciences in Spain?
As a global leader in patient-focused medical innovations, we offer rewarding opportunities and exciting challenges in a truly international, dynamic and friendly work environment.
We are committed to fostering a diverse and inclusive work environment where all employees can grow, personally and professionally. To achieve this, we offer on-the-job development, training opportunities and the support and guidance provided by dedicated employee groups.
Edwards Lifesciences in Spain also offers the following benefits:
Competitive Compensation and Benefits package
Pension plan
Life Insurance
Medical plan
Service Awards
Enhanced Leave benefits
Employee Stock Purchase Programme
Employee Assistance Programme
Comprehensive Wellness programme
Benefits are regulated by an internal policy which contains the full details regarding the entitlement and conditions for the benefits. Benefits policy and components may vary by location.
Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement.
For US Applicants Only Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers, the California Fair Chance Act, and any other applicable regulation.

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