Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future.
Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients.
Powered by our purpose – the relentless pursuit of a world that works better for people – we serve and transform leading enterprises, including the Fortune Global 500,` with our deep business and industry knowledge, digital operations services, and expertise in data, technology, and AI.Inviting applications for the role of Senior Associate-Complaint Evaluator What will your day-to-day role involve?
Responsibilities Communicates verbally and in writing both internally and externally with client regarding information needed specific to new product complaints (e.g.
physicians, hospital personnel, sales representatives, international offices), initiates and manages the complaint file Collaborating with local Complaint intake teams to verify or request additional information to help evaluate complaint.
Collaboration within the team, peers and managers to provide update and share information.
Participate and lead activities assigned by Manager and update internal and external stakeholders.
Participate in client and team internal meetings / Conference calls as needed Investigates complaints/events in a timely manner.
Maintains accurate entry of complaints in database.
Independently assesses the complaint to determine next steps and follows QMS process as agreed with client.
Ensuring completeness of complaint records through Vigilance due diligence tasks Ensuring completeness of records due to wrong/missing information due diligence tasks Initiating continuous improvement activities Monitoring source (data entry) system updates Assisting Global Complaints Handling Management in the successful identification and resolution of quality issues associated with complaints Maintaining quality records to ensure compliance with global client´s requirements Serve as a backup for the Global Vigilance team to support high volume spikesDetermine the severity of the problem and next actions.
Entering info from the service report into the digital tool (ERP) - ETQ Make a decision and complete evaluation by classifying the issue into a tier.
Explain complaint files during audit situations.
Reviews files for closure and completeness.
Determination if investigation is required (Tier determination) Final evaluation & closure of complaints Translate any document required from Spanish to English or English to Spanish Work any other activity related to an inquiry or complaint as part of the end to end cycle of the transaction or the end to end process Qualifications we seek in you!
Minimum qualifications Bachelor of Science , Engineering or Biomedical engineering degree with a minimum of 1-3 years medical device experience or Minimum of 1-3 years medical device experience (i.e.
LPN, Associate RN, X-Ray technician, Biomedical technician, Nurse) Critical thinking / decision making Administrative duties - precision, data accuracy Preferred Qualifications Communications - investigative affinity Quality assurance background/medical device background.
Potentially candidates with previous SQE or Technical support experience Asking the right questions Demonstrated working knowledge of Medical Device Quality Systems regulations (e.g.
ISO 13485, EU-MDR 2017/745, 21CFR820) Is Great to haveEnglish Proficiency.
"The approximate monthly base compensation range for this position is CRC 90,000 per month.
The actual offer, reflecting the total compensation package plus benefits will be determined by a number of factors which include but are not limited to the applicant's experience, knowledge, skills, and abilities; geographic location; and internal equity."