Quality Professional - Bengaluru, India - Siemens Healthineers

Siemens Healthineers

Verified Company

Bengaluru, India

2 weeks ago

Posted by:

Deepika Kaur

beBee Recuiter

Description

Job description:

Evaluate safety complaint escalations, 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.
File MDRs when needed and communicate (as appropriate) to the EU Authorized Representative or Regional Unit.
Work with members of other teams to review, assess, and close potentially adverse events (pMDRs), including MDR reporting related to Laboratory Diagnostics (LD) BA product lines.
Provide support in all areas associated with Medical Device Report (MDR) / Medical Device Vigilance Report (MDVR) / Medical Device Problem Report (MDPR-Canada) reporting and trending.
In addition, support the Commercial Product Quality (CPQ) department when working on post market 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 highimpact, complex, and/or crossfunctional problems is expected.
Demonstrate a significant knowledge of organization's business practices and issues faced and contributions to problem resolution of those issues.
Display an understanding of clinical laboratory invitro diagnostics testing

Requirements:

23 years of experience with Medical Device Reporting (US and Outside of the US).
Good writing, communication and organizational skills necessary.
Education: 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

Organization:
Siemens Healthineers

Company:
Siemens Healthineers India LLP

Experience Level:
Experienced Professional

Full / Part time:
Full-time