QA / QC Manager – FILLED
QA / QC Manager from The Wellington Group @twgrecruiters
The Wellington Group has been engaged to find a QA / QC Manager with experience ranging from batch release to QC inspections. Put your QA/QC Manufacturing experience to work in a new job today!
The QA / QC Manager, is responsible for various assigned cGMP compliance activities. This includes managing the following areas within the Quality organization: Batch Release, QC Inspection, and manufacturing floor quality process to oversee quality/compliance. These activities include the improvement, development and implementation of quality processes to ensure that the development, manufacture and distribution of medical products is in compliance with company policies and procedures, FDA, ISO, CMDR, the Medical Device Directive, and other applicable regulatory agencies.
Requirements:
- Oversee QC Inspection group including incoming inspection, in-process testing, line clearance and final release of product
- Oversee review and approval of product labels, including changes to labeling
- Update and improve procedures that are used within the QA/QC areas
- Conduct training of staff as required
- Assist in managing materials that are under investigation via the Nonconformance System
- Managing the quarantine process for all raw materials, in-process and finished goods/products
- Ensure all Quality records pertaining to QC inspection and Batch Release are retained
- Ensure overall compliance level is appropriate for GMP activities
- Participate in the Product Quality Reviews to ensure timely review and completion of open items
- Develop and report key metrics for QC Inspection, Batch Release and Quality on Floor areas
- Conduct trend analysis of metrics and suggest improvements that can drive overall efficiency and improved compliance
- Direct supervision of: Quality Assurance Release Specialists, Quality Control Inspectors and Quality Associates on the floor in support of manufacturing
The qualified candidate will have:
- BS Degree in Engineering, MS Degree is preferred
- 6+ years of experience in Medical Devices, Pharmaceuticals or Biologics
- 3+ years in a supervisory role
- ASQ Certification and TQM experience desired
- Database and quality data reporting experience required, experience working with Oracle is a plus
- Demonstrated knowledge of FDA regulations, ISO 9001, ISO 13485:2003, CMDR, Medical Device Directive Regulation
Industry: QA, QC Inspections, Batch Release, Device History Records (DHR), FDA, ISO 9001, ISO 13485:2003, CMDR, Medical Device Directive, training, Oracle
Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)
The Wellington Group ( https://twgrecruiters.com) 910-338-2795