Quality Professional - Commercial Product Quality

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 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.

· Display an understanding of clinical laboratory in-vitro diagnostics testing

Requirements:

· 2-3 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 and external contacts.