Quality & Complaint Investigator – Medical Devices

Edwards; Indianapolis (IN); In loco; USD 70.000 - 95.000; Tempo pieno

Descrizione del lavoro

Edwards is seeking a Quality Compliance professional to support complaint handling and regulatory reporting. You will partner with Product Safety, Engineering and other departments to investigate and resolve complaints, ensuring MDR submissions and GDP compliance.

The role emphasizes attention to detail, strong communication, and the ability to manage multiple priorities in a fast-paced medical device environment.

Competenze

• 3 years’ experience complaint handling.
• Strong written and verbal communication and interpersonal skills.
• Experience with regulatory reporting and MDR processes.
• Familiarity with GDP and good documentation practices.
• Ability to work cross-functionally and manage competing priorities.

Mansioni

• Assess complaint information and determine if it qualifies as a complaint.
• Manage customer relationships during investigation and resolution.
• Coordinate input from Product Safety, Engineering and other units.
• Identify problems and lead process-improvement projects.
• Evaluate complaints for MDR and prepare FDA reports.
• Summarize findings and formulate conclusions.
• Prepare and submit final customer correspondence.
• Support audit activities and other duties as assigned.

Conoscenze

Complaint handling

Written & verbal communication

Interpersonal skills

Attention to detail

Strumenti

MS Office Suite

Documentation management

Descrizione del lavoro

Edwards is seeking a Quality Compliance professional to support complaint handling and regulatory reporting. You will partner with Product Safety, Engineering and other departments to investigate and resolve complaints, ensuring MDR submissions and GDP compliance.

The role emphasizes attention to detail, strong communication, and the ability to manage multiple priorities in a fast-paced medical device environment.