Complaint Vigilance Investigator- Contract
Intuvie, Natick, MA, United States
The Complaint Vigilance Specialist provides day-to-day support in the complaint handling process from intake to closure through timely follow up, assessment, processing, and documentation of customer complaints in compliance with government regulations and standards. This position works closely with the Service, Customer Service, Quality, Regulatory and Engineering Teams.
ESSENTIAL JOB FUNCTIONS
Review and analyze customer feedback to determine if feedback meets the definition of a complaint.
Triage customer feedback or questions and initiate complaints into the database.
Collaborate with Customer Service and Operations teams to facilitate the complaint handling process.
Follow up with the complainant to obtain missing information (GFE’s) needed for the complaint process.
Maintain accurate complaint records for compliance purposes.
Escalation to Management of potential safety issues or issues that could impede the ability to process complaints and close records.
OTHER DUTIES AND RESPONSIBILITIES
Identifies potential concerns and escalates to management when necessary
Provides support of CAPAs and NC’s as necessary
Train to all assigned SOP’s, WI and templates/forms
Additional responsibilities may or may not be assigned to the employee; role assignment will be reviewed on a case-by-case basis determinant upon individual strengths, experience, knowledge, and expertise.
PREPARATION, KNOWLEDGE, SKILLS & ABILITIES
Minimum 1-2 years complaint handling experience within an electronic system required
Accuracy, attention to detail, and thoroughness required
Experience in Medical Device industry a plus
Knowledge of 21CFR 820 Quality System Regulations
Strong communication and excellent data analysis skills
Team player as well as an individual contributor that can work independently to achieve goals.
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ESSENTIAL JOB FUNCTIONS
Review and analyze customer feedback to determine if feedback meets the definition of a complaint.
Triage customer feedback or questions and initiate complaints into the database.
Collaborate with Customer Service and Operations teams to facilitate the complaint handling process.
Follow up with the complainant to obtain missing information (GFE’s) needed for the complaint process.
Maintain accurate complaint records for compliance purposes.
Escalation to Management of potential safety issues or issues that could impede the ability to process complaints and close records.
OTHER DUTIES AND RESPONSIBILITIES
Identifies potential concerns and escalates to management when necessary
Provides support of CAPAs and NC’s as necessary
Train to all assigned SOP’s, WI and templates/forms
Additional responsibilities may or may not be assigned to the employee; role assignment will be reviewed on a case-by-case basis determinant upon individual strengths, experience, knowledge, and expertise.
PREPARATION, KNOWLEDGE, SKILLS & ABILITIES
Minimum 1-2 years complaint handling experience within an electronic system required
Accuracy, attention to detail, and thoroughness required
Experience in Medical Device industry a plus
Knowledge of 21CFR 820 Quality System Regulations
Strong communication and excellent data analysis skills
Team player as well as an individual contributor that can work independently to achieve goals.
#J-18808-Ljbffr