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 managerEvaluate event to determine if it qualifies as a complaintManage customer relationship and expectations during course of complaint investigation and resolution processAssess complaint information provided and conduct additional investigation as needed and escalate as appropriateEvaluate complaints for Medical Device Reporting to competent authoritiesPrepare and submit reports to Competent Authorities, after review by more senior team memberSummarize 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 conclusionsPrepare and submit final customer correspondence, after review by more senior team memberOther incidental duties; May identify problems with processes, procedures, and/or practices, and recommend solutions, including devising new approaches to problems encounteredWhat You'll Need (Required): Bachelor's Degree in related field, 1 year experience complaint handling-similar experience RequiredExperience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment PreferredWhat Else We Look For (Preferred): Good computer skills in MS Office Suite and ability to operate general office machineryGood written and verbal communication skills and interpersonal relationship skillsGood problem-solving and critical thinking skillsModerate knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality complianceBasic knowledge of medical terms and human anatomyFull knowledge of Medical Device Vigilance regulations, and regulatory reporting regulationsGood knowledge of Good Documentation Practices (GDP) as it relates to complaint filingAbility to manage confidential information with discretionAttention to detailAbility to interact professionally with all organizational levelsAbility to manage competing priorities in a fast paced environment with guidanceMust be able to work in a team environment, including immediate supervisor and other team members in the section or groupAbility to build stable internal/external working relationshipsAdhere 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/controlWhat 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 (the Edwards Network of Women, Edwards Foundation charity team, sustainability activities, and others).
Edwards Lifesciences in Spain also offers the following benefits:
Competitive Compensation and Benefits packageFlexible working hours, remote workingPension planLife InsuranceMedical planMeal VouchersService AwardsEnhanced Leave benefitsEmployee Stock Purchase ProgrammeEmployee Assistance ProgrammeComprehensive Wellness programme including gym membership reimbursement, fresh fruit in the office, yoga lessons, subsidized massages, mindfulness sessions, educational events, charity activities and much more.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.
Job referenceReq-37170
TypeFull time
LocationSpain-Valencia
Posted for1 day ago
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