Complaint Handling Specialist

Fujifilm – Bismarck, North Dakota

Role Overview

The Complaint Handling Specialist position at Fujifilm Healthcare Americas Corporation in Bismarck, North Dakota is designed to provide comprehensive support for complaint handling. This role ensures full and ongoing compliance with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, as well as the ISO 13485 standard and other relevant laws, regulations, and standards.

<h2-Core Duties

• Respond to customer complaints in a timely and professional manner, ensuring all necessary documentation is accurately recorded and communicated.
• Conduct investigations into reported issues, gathering data and evidence to determine the root cause of problems.
• Work closely with cross-functional teams including quality assurance, manufacturing, and regulatory affairs to resolve complaints effectively and efficiently.
• Update and maintain complaint handling records in compliance with FDA and ISO standards.

<h2-Requirements

• Bachelor's degree in a relevant field such as healthcare, engineering, or quality management.
• Minimum of 3 years' experience in medical device complaint handling or related areas.
• Strong knowledge of U.S. FDA regulations and ISO 13485 standards.
• Excellent communication skills with the ability to interact effectively with customers at all levels.
• Proficient in using Microsoft Office Suite and other relevant software tools.

<h2-Why Join Fujifilm

Joining Fujifilm offers a dynamic work environment where you can contribute to innovation and excellence in the medical device industry. Our commitment to quality, customer satisfaction, and continuous improvement provides numerous opportunities for professional growth and development. As part of our team, you will be working with leading-edge technologies and collaborating with highly skilled professionals.

<h2-Next Steps

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there. Please ensure all required fields are filled out accurately for a smooth submission process.