What Our Clients Say

insulet

I can’t say enough about QSCS. While we initially hired their services to manage several projects focused on upgrading our quality system, their professionalism and customer service made them an easy choice to help support us project manage and complete all requisite validation activities for the startup of a $200MM+ manufacturing facility. Their team worked seamlessly with all levels and functions of our organization managing and completing 100s of validations, leading to the successful production/launch of our devices from this new state of the art facility.

Kim Ruzek
Vice President, Quality Systems and Operations
Insulet Corporation
angiodynamics

QSCS was hired to help support Operational Excellence activities within one of our manufacturing facilities. Within six months, their program leader had trained thirty members of our team on LEAN principles and had run multiple successful Kaizen events, one of which saw us redesigning our entire manual assembly operations for one of our product lines, saving 25% of our work space and reducing labor requirements by 40%! When we originally contacted QSCS, they mentioned their goal was to be “Revenue Neutral”. Well, they far surpassed that, we actually came out positive on this engagement!

After a successful Operation Excellence engagement, we enlisted the services of QSCS again to help us to support our EUMDR compliance plan while at the same time help us move nine separate production lines into a new manufacturing facility, including the handling of all of the project management and validation activities. We are EUMDR compliant and our equipment move and validations were done successfully and on time!

Warren Nighan
Senior Vice President, Quality and Regulatory Affairs
ICU Medical
Angiodynamics Inc.
hospira logo

In response to a significant set of agency findings and the creation of a Corporate Compliance Master Plan, we enlisted the services of QSCS to work with us to support the development and implementation of a comprehensive remediation plan. In a short period of time, they were able to assemble a very professional and highly qualified team covering all areas of our global quality system. They helped lead and direct multiple QMS work streams to identify immediate actions needed to correct existing deficiencies, install interim controls, and develop and implement long term corrective actions. Their breadth of experience also provided us with audit response support at a moment’s notice. Project completion saw multiple zero-483 audits and the lifting of an export ban. In addition, the project was under budget and on schedule! Really the best!

Joseph Sener
Vice President Quality, Device Engineering
ICU Medical
Hospira Corporation

Clear guidance by utilizing centuries of FDA and INDUSTRY EXPERIENCE along with a passion and history of applying OPERATIONAL EXCELLENCE to deliver our unique VALUE PROPOSITION: REVENUE NEUTRAL COMPLIANCE

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