I'm partnering with a large organization who are working on Medical Devices, Combination Products and Pharmaceuticals to secure a Global Quality Assurance Manager on a maternity cover contract until the end of 2019.
This is part remote (3 days/week max remotely & 2 days/week on site in PA) and pays up to $75/hour all-inclusive rate on a W2 basis. **No C2C / No Sponsorship**
Your key responsibilities will center on:
- Managing quality programs to improve total quality of company product and processes
- Overseeing implementation and compliance with ISO and other applicable quality standards
- Researching, analyzing and reporting quality trends and other data.
- Batch lead and release
- Supplier management, CMO, vendor management
- Complaints investigation and reporting
- **Potentially the management of two Quality Engineers
Key Experience Required:
- 8+ years of experience in a QA/QC Management role
- Medical device industry experience in a Quality Assurance function (Combination product experience is preferred)
- In-depth understanding on FDA CFR 820 & 803 and ISO 13485
- Experience in Supplier Management, Batch lead and release and Medical Device Reporting is imperative
- Experience & knowledge of international regulations is a huge plus (eg. Japan, Australia, Brazil)
If this is of interest apply now!
Sthree US is acting as an Employment Business in relation to this vacancy.