**Location**:
Cartago, Costa Rica, CR
**Job Family**: Quality Assurance
**Country/Region**: Costa Rica
**Job Function Summary**:
The Complaint Handler Technician will evaluate, investigate, and resolve complaints of various products from different countries, initiate corrective and preventive actions when needed, analyze complaint data, gather additional data as needed and provide feedback to the manufacturing functions on potential process improvements, product defects and safety evaluations.
The Complaint Handler Technician will also serve on the QA team to ensure processing of complaints with proper evaluation and documentation, and in timely manner according to local and global procedures.
**Major Areas of Accountability**:
Daily handling of complaints including entering information in the Coloplast complaint database (TrackWise)
Analysis of complaint data and investigation of products, provision of data for production
Interpret and analyse data to identify trends
Monitoring of complaint trending (trend analysis) for quarterly product review meetings
Initiating corrective and preventive actions for operational quality assurance engineers and production support engineers and monitoring of these activities
In case of a serious incident, escalation to Management, and involving the responsible(s) in the process
Comply with internal instructions and work discipline in connection with work
Scheduling training of the complaint process for local users or knowledge sharing
Ensure continued preparedness from the "know-how" of the products / technologies involved
Create/update, document, and implement relevant procedures
Work with Global Process owner and complaint initiators / investigators to ensure compliance to the complaint handling process
Participation on cross-functional teams
Perform other duties within quality processes, as necessary
Prepare and sign certificates for those countries who has requested, this task is delegated by Head of Quality Cartago.
Performing their job in compliance with the guidelines given
Drawing attention to the manager to any difficulties in understanding or following the guidelines
Drawing attention to inefficiency of the system
Take responsibility for those safety aspects identified for the given position
**Essential Qualifications**:
Technical degree in Productivity or Quality
**Computer knowledge and good typing skills required**: MS Office (Word, Excel), Outlook and databases
Experience with TrackWise is preferred, but not a requirement
Working knowledge within medical device industry and regulations
**Responsible for**:
Performing their job in compliance with the guidelines given
Drawing attention to the manager to any difficulties in understanding or following the guidelines
Drawing attention to inefficiency of the system
**Required Knowledge, Skills and Abilities**:
Relevant experience supporting complaint handling investigations, medical device reporting, or related work
Knowledge or medical device regulations
Self-motivation and a genuine interest in improving processes and internal customer relationships
Ability to meet deadlines
Capable of interpreting data, and generating CAPAs
Good communication skills (verbal and written) in English
Good documentation and time management skills
Must work well in a team and be adaptable/flexible
Attention to detail and the ability to follow work instructions
An understanding of the importance of customer focus
Ability to effectively interact with various internal and external customers/ vendors
Must work well independently and be adaptable/flexible with team members
Ability to maintain a good working relationship with coworkers and staff
Ability to multi-task
Ability to organize efficiently and effectively, good structure
Ability to convey a positive and professional image to internal and external customers
Ability to exercise logical and sound judgment
Listening
- practices at tentative and active listening; has the patience to hear people out; can accurately restate the opinions of others even when he/she disagrees
Proficient problems solving skills
Why Coloplast?
Coloplast develops products and services that make life easier for people with personal and private medical conditions.
Working closely with the people who use our products, we create solutions that are sensitive to their special needs.
We call this Intimate healthcare.
**We are guided by three values**:
**Closeness**: we work closely with our customers to find solutions that meet their specific needs.
**Passion**: we work passionately to create new and innovative products that improve the quality of life for our customers.
**Respect and responsibility**: we have deep respect for the private nature of the condition our customers face.
Therefore, it's our responsibility to find not only medical solutions, but also ways to minimize the trauma and taboo associated with these conditions.
Our business includes Ostomy