Job Description
True to the vision “We drive innovation to improve people's lives”, the Hamilton companies have been providing solutions for the health sector since 1950. We are an innovative pioneer in the fields of ventilators, automated pipetting, sample management and in the development of process sensors.Hamilton Medical is a leading manufacturer of intelligent ventilators. Whether in ICUs, during emergency rescue transport or an MRI scan – our solutions cover a multitude of patient groups, applications and environments.
- Act as the process owner for all incoming product complaints
- Receive, register, and evaluate the complaint information for acceptance or rejection and justify the decision
- Perform initial assessment for reportability and escalate complaints determined as reportable to Vigilance
- Ensure that complaint investigations are appropriately performed and documented
- Perform final review of the complaint inculuding final assessment based on investigation results or any additional information received
- Determine the need for a CAPA request based on investigation findings
- Perform process monitoring and measurement
- Provide the complete IMDRF rating according to the complaint investigation report
- Bachelor's degree preferred, or equivalent combination of education and experience
- 3+ years experience in processing complaints and performing triage and investigations, ideally in the medical device
- Speaks/writes/reads English (fluent or native)
- Profound experience with reading and interpreting device diagnostics and troubleshooting with medical devices with demonstrated experience in change management
- Background in Post Market Surveillance and Health Hazard Evaluation process an advantage
- Proven experience in working with complaint management systems (Ky2Help, Service-Now, ETQ, MasterControl, etc.)
- Experience with intercultural teams in global matrix organization
- Recognized expertise in electronics, electromechanics and/or biomedical
- Experience with communication to local authorities (FDA, SwissMedic, BfArM, …) and medical device regulation (EU) 2017/745 as well as with American FDA laws a plus
- International travel requirement up to 20%
- Staff discounts for many leisure activities and services
- Green Sense: The healthy and sustainable staff restaurant
- Sports & Fun – see what surprises lie in store
- Advisory services provided by external partners for various life situations
- Diverse opportunities for further training and development
- An informal working environment
- Compensation time for bridging days between Christmas and New Year
- A dedicated pension fund with the possibility to choose from three options
You have the option of working from Domat / Ems (CH, with max. 20% home office) or from Germany (100% home office).View More