Quality Compliance Associate - Impact Medical Devices

Edwards Lifesciences; Valencia; Presencial; EUR 28 000 - 38 000; Tempo integral

Resumo da oferta

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.

Qualificações

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

Responsabilidades

• 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.

Conhecimentos

Problem solving

Communication

Attention to detail

GDP knowledge

Regulatory knowledge

Formação académica

Bachelor's degree in related field

Descrição da oferta de emprego

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.