Specialist, Quality Compliance

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 package
• Flexible working hours, remote working
• Pension plan
• Life Insurance
• Medical plan
• Meal Vouchers
• Service Awards
• Enhanced Leave benefits
• Employee Stock Purchase Programme
• Employee Assistance Programme
• ComprehensiveWellness 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.