Quality Professional -
Commercial Product Quality Job
description: assess and make decisions on medical device reporting (Medical Device Report(MDR)-MedWatch Form
3500A),in accordance with 21 CFR 803, and documenting
those decisions.
EU Authorized
Representative or Regional Unit. Laboratory Diagnostics (LD)
BA product lines. edical Device Report (MDR)
/ Medical
Device Vigilance Report (MDVR) / Medical Device Problem Report (MDPR-Canada) reporting and
trending.
LD product line issues. Provide CPQ support for LD Product Health Teams.
Display of a high level of critical thinking in bringing
successful resolution to high-impact, complex, and/or cross-functional problems
is expected. Demonstrate a significant knowledge of organization's business
practices and issues faced and contributions to problem resolution of those
issues.
Requirements: 2-3 years of experience with Medical Device Reporting (US and
Outside of the US). Good writing, communication and organizational skills necessary.
BS/BA in related
discipline, or advanced degree, where required, or equivalent combination of
education and experience. Certification may be required in some areas.
Key
Working Relationships: Primarily intra organizational contacts and external
contacts. Organization: Siemens Healthineers Company: Siemens Healthcare Private Limited Experience