**Location**:Cartago, Costa Rica, CR**Job Family**: Quality Assurance**Country/Region**: Costa Rica**Job Function Summary**:The Complaint Handler will evaluate, investigate the complaints of various products from different countries in regards Coloplast Cartago production. Together with complaint-team and responsible engineers 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 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 factory meetings and quarterly product review meetings- Making regular and ad hoc reports- Together operational quality assurance engineers and production support engineers Initiating corrective and preventive actions and monitoring of these activities- Ranking and reporting the serious incident and negative trends towards the local / global Quality departments- Comply with Coloplast procedures and 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- As Local Process Owner work with Global Process owner and complaint initiators / investigators to ensure compliance to the complaint handling process- Represent the site in internal and external audits in regards Complaints of Cartago site- Participation on cross-functional teams- Support the organization in questions and to help resolving issues, concerning Complaint handling.- Participate in development of complaint report structure and reporting of targets.- Participate in development and improvements of Complaint handling system and process.- 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**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**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**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 skillsWhy 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 th
