Lead Engineer-Medical Devices-Complaint Handling

Description

We are seeking a highly skilled and experienced Lead Engineer-Medical Devices-Complaint Handling to join our team. The successful candidate will be responsible for managing all aspects of complaint handling and investigation activities for our medical devices portfolio.

Responsibilities

• Develop and implement complaint handling procedures in compliance with regulatory requirements
• Lead and manage complaint investigations to ensure timely resolution and appropriate corrective actions
• Collaborate with cross-functional teams to identify and implement process improvements
• Assist in the preparation and submission of regulatory reports related to complaint handling
• Act as the primary point of contact for all complaint handling related inquiries from regulatory agencies
• Conduct training and provide guidance to team members on complaint handling procedures and best practices

Skills and Qualifications

• Bachelor's degree in engineering, science, or related field
• 2-7 years of experience in medical device complaint handling
• Strong understanding of global regulatory requirements for complaint handling
• Excellent analytical and problem-solving skills
• Ability to work independently and in a team environment
• Excellent communication and interpersonal skills
• Experience in leading and managing teams