Job Title - Quality Engineer
Job Location - Santa Ana, California
HM's Top Needs :
- Experience in Complaint handling, complaint investigation and root cause analysis for Medical Devices
- Ability to work cross-functionally and deliver consistent outputs to meet set targets.
- Strong knowledge of cardiovascular diseases, use of heart valves and catheters
Responsibilities may include the following and other duties may be assigned.
- Conducts complaint investigations for Structural Heart devices. This includes performing intial assessment to create appropriate tasks or technical assessments in the Global Complaint Handling (GCH) system, for example - DHR reviews, Manufacturing assessment, R&D assessment ,etc.
- Performing thorough review of these assessments by working with cross-functional teams (like Medical Safety, Manufacturing, Operations Quality, R&D, Design Assurance and Customer Quality Teams) across multiple sites and time zones globally.
Summarizing the results of these assessments into the complaint investigation summary in a timely manner to ensure timely closure of the overall event.
To be able to consistently close complaint investigations to meet weekly target volumes.
- Ensuring timely completion of complaint investigations to sustain a compliant timeliness metric / KPI for the entire Operating unit.
- Presenting complaints on a weekly basis and escalating events that meet certain criteria. To be able to communicate complaint information across all levels in the organization.
- Supporting regulatory submissions and regulatory inquiries on complaints by working closely with Customer Quality Experience Management team (CQXM) and providing complaint data as requested.
- Ability to present the complaint investigation in an audit when needed.
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