Manufacturing Site Service Provider Medical Devices: New Jersey

QSCS was hired to focus on two directives.

The first was to provide full remediation and audit support in response to an FDA Warning letter.  A thorough gap assessment was performed on each Quality Subsystem followed by the development and implementation of a remediation strategy.  The gaps in each subsystem were corrected.   The team effort between the client and QSCS lead to a zero observation-483 audit.

The second directive was to help separate one of their service businesses by developing and implementing a completely new (properly focused/sized/LEAN) quality system.  This was successfully implemented which reduced the size of the Quality System by 70%.

In addition to the items found on the SOW:

While working on the Quality System separation for the $45MM service business, the QSCS consultant identified LEAN opportunities within their procurement system leading to an inventory reduction of $1.4MM.

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