Specialist, Quality Compliance

hace 2 semanas

Valencia, Valencia, España Edwards Lifesciences A tiempo completo

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 will make an Impact:

Investigate complaints that include moderately complex scenarios:
o Evaluate event to determine if it qualifies as a complaint

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

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

o Seek information and input, and challenge as appropriate, from Product Safety, Engineering and other

departments/business units for complaint investigations

o Evaluate complaints for Medical Device Reporting to competent authorities

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

o 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

o 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 in related field , 3 years years experience of complaint handling-similar experience Required and

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

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

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 (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 Vouchers Service AwardsEnhanced Leave benefitsEmployee Stock Purchase ProgrammeEmployee Assistance ProgrammeComprehensiveWellness programme including gym membership reimbursement, fresh fruit in theoffice, 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.

#J-18808-Ljbffr

  • Specialist, Quality Compliance

    hace 2 semanas

    Valencia, Valencia, España Edwards Lifesciences Gruppe A tiempo completo

    We have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience. Specialist, Quality Compliance page is loaded Specialist, Quality Compliance Apply locations Spain-Valencia time type Full time posted on Posted 3 Days Ago job requisition id Req-34020 Fulfill...

  • Specialist, Quality Compliance

    hace 2 semanas

    Valencia, Valencia, España Edwards Lifesciences Gruppe A tiempo completo

    We have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience. Specialist, Quality Compliance page is loaded Specialist, Quality Compliance Apply locations Spain-Valencia time type Full time posted on Posted 3 Days Ago job requisition id Req-34020 Fulfill...

  • Specialist, Quality Compliance

    hace 2 semanas

    Valencia, Valencia, España Edwards Lifesciences Gruppe A tiempo completo

    We have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience. Specialist, Quality Compliance page is loaded Specialist, Quality Compliance Apply locations Spain-Valencia time type Full time posted on Posted 3 Days Ago job requisition id Req-34020 Fulfill...

  • Supplier Quality Specialist

    hace 2 semanas

    Valencia, Valencia, España Chipton-Ross Inc A tiempo completo

    Chipton-Ross is seeking a Supplier Quality Specialist 3 for a contract opportunity in Valencia, CA.POSITION RESPONSIBILITIES:o Plans and conducts audits and assessments of supplier's systems, processes and products.o Documents and reports audit and assessment results.o Inspects or verifies products for compliance with requirements.o Assists with assessments...

  • Specialist, Quality Compliance

    hace 2 semanas

    Valencia, Valencia, España Edwards Lifesciences A tiempo completo

    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 will make an Impact: Investigate complaints that include moderately complex scenarios:o Evaluate event to determine if it qualifies as...

  • Specialist, Quality Compliance

    hace 2 semanas

    Valencia, Valencia, España Edwards Lifesciences A tiempo completo

    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 will make an Impact: • Investigate complaints that include moderately complex scenarios: o Evaluate event to determine if it...

  • Specialist, Quality Compliance

    hace 2 semanas

    Valencia, Valencia, España Edwards Lifesciences A tiempo completo

    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 will make an Impact:Investigate complaints that include moderately complex scenarios:o Evaluate event to determine if it qualifies as a...

  • Associate Quality Compliance Specialist

    hace 5 días

    Valencia, Valencia, España Edwards Lifesciences A tiempo completo

    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 will make an Impact:• Investigate complaints with the support of higher level team member or managero Evaluate event to determine if...

  • Intern, Quality Compliance

    hace 1 mes

    Valencia, Valencia, España Edwards Lifesciences A tiempo completo

    Make a meaningful difference to patients around the world. Our International Quality Program is designed to help early-career professionals contribute to solutions that transform patient lives. We also believe in investing in the future of our talented people across the globe, including early career professionals seeking to explore and establish themselves...

  • Intern, Quality Compliance

    hace 2 semanas

    Valencia, Valencia, España Edwards Lifesciences A tiempo completo

    Make a meaningful difference to patients around the world. Our International Quality Program is designed to help early-career professionals contribute to solutions that transform patient lives. We also believe in investing in the future of our talented people across the globe, including early career professionals seeking to explore and establish themselves...

  • Intern, Quality Compliance

    hace 4 semanas

    Valencia, Valencia, España Edwards Lifesciences A tiempo completo

    Make a meaningful difference to patients around the world. Our International Quality Program is designed to help early-career professionals contribute to solutions that transform patient lives. We also believe in investing in the future of our talented people across the globe, including early career professionals seeking to explore and establish themselves...

  • Quality Supervisor

    hace 2 semanas

    Valencia, Valencia, España Adm A tiempo completo

    Job DescriptionAt ADM, we unlock the power of nature to provide access to nutrition worldwide. With industry-advancing innovations, a complete portfolio of ingredients and solutions to meet any taste, and a commitment to sustainability, we give customers an edge in solving the nutritional challenges of today and tomorrow.We're a global leader in human and...

  • Intern, Quality Compliance

    hace 2 semanas

    Valencia, Valencia, España Edwards Lifesciences A tiempo completo

    Make a significant impact on patients worldwide with our International Quality Program tailored for early-career professionals to contribute towards enhancing patient outcomes. We believe in nurturing talent globally, especially those new to the medical device sector. As an intern here, you'll excel in a vibrant, patient-centric setting, influencing...

  • Intern, Quality Compliance

    hace 2 semanas

    Valencia, Valencia, España Edwards Lifesciences A tiempo completo

    Make a meaningful difference to patients around the world. Our International Quality Program is designed to help early-career professionals contribute to solutions that transform patient lives. We also believe in investing in the future of our talented people across the globe, including early career professionals seeking to explore and establish themselves...

  • Quality Compliance Intern

    hace 2 semanas

    Valencia, Valencia, España Edwards Lifesciences A tiempo completo

    Edwards Lifesciences, a global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring, is looking for an enthusiastic student, who would like to join the Quality team in Valencia and help manage our complaint handling. That includes fulfillment of applicable medical device regulations in...

  • Compliance Manager

    hace 2 semanas

    Valencia, Valencia, España LanguageWire A tiempo completo

    Would you like to contribute to the continued development of information security and GDPR compliance in an international organization? Are you able to communicate GDPR and other data protection-related information in an understandable way to our organization and customers? Do you want to work in a world-class language service provider driven by tech? Then...

  • Quality Assurance Manager

    hace 2 semanas

    Valencia, Valencia, España Apeel Sciences Careers A tiempo completo

    At Apeel, we look to nature to help the global food system extend quality, prevent waste, and ensure an abundant future for our planet.We believe that our most essential ingredient in our recipe for success is our people. We strive to cultivate an environment where everyone is welcomed, and can bring their full, authentic selves into everything they do at...

  • Purchasing Specialist

    hace 2 semanas

    Valencia, Valencia, España Acttif A tiempo completo

    Select how often (in days) to receive an alert:Purchasing Specialist BTM & CTM (all genders)ProcurementIProfessionalsWith whom you will CELLebrateThe mission has started. We proudly announce that we are starting the ramp-up of our own cell manufacturing in Valencia. In this significant phase, the role of a Purchasing Specialist becomes increasingly vital. As...

  • Purchasing Specialist

    hace 2 semanas

    Valencia, Valencia, España Acttif A tiempo completo

    Select how often (in days) to receive an alert: Purchasing Specialist - BTM & CTM (all genders) Procurement I Professionals With whom you will CELLebrate The mission has started. We proudly announce that we are starting the ramp-up of our own cell manufacturing in Valencia. In this significant phase, the role of a Purchasing Specialist becomes increasingly...

  • Purchasing Specialist

    hace 2 semanas

    Valencia, Valencia, España Acttif A tiempo completo

    Select how often (in days) to receive an alert:Purchasing Specialist BTM & CTM (all genders) Procurement I ProfessionalsWith whom you will CELLebrateThe mission has started. We proudly announce that we are starting the ramp-up of our own cell manufacturing in Valencia. In this significant phase, the role of a Purchasing Specialist becomes increasingly vital....