Job Description

The Role:

As a Complaint Specialist, you will ensure compliance to product complaints and the complaint handling system with the responsibility of timely complaint assessment and closure while collaborating with cross-functional teams such as Customer Service, Quality, Engineering, Logistics to facilitate the complaint handling process. In this role, you will:

• Review product complaint information in database, confirm complaint condition to determine necessary action, including CAPA
• Evaluate and investigate potential MDR reportable events to determine if reporting is needed
• Collaborates with cross-functional teams and 3P investigators to ensure additional information is gathered for complaint review/investigations.
• Review complaint against risk matrix and determine if the risk assessment is covering the hazard in the complaint
• Evaluate and track complaints through complaint process workflow to closure
• Prepare ad-hoc reports on needed basis
• Ability to analyze data, looking for trends to summarize and report findings
• Responsible for updating work instructions to capture process changes
• Coordinate and compile team metrics to support monthly team meetings
• Coordinates and prioritizes complaint investigations according to risk

BASIC QUALIFICATIONS:

• 5+ years of experience in a complaint handling role in a regulated medical device industry.
• Good understanding of FDA regulations 21 CFR Part 820 and ISO13485

Preferred Qualifications:

• Excellent written and verbal communication skills
• Strong organizational skills
• Exceptional attention to detail
• Can work independently and collaboratively
• Ability to prioritize workload and multi-task within strict time frames
• Proficiency using office tools such as Excel and Visio

Job Tags

Similar Jobs