Quality Assurance
Are gaps in your Quality System and/or Quality Assurance practices keeping you up at night?
Select from our services below to help bring on a good night's rest!
Quality Management and Audits
Our quality team can help create, review, execute/manage, audit or advise on your quality management system to ensure the right focus and size to best fit your products and company. Additionally, our team of experienced auditors can support quality system maintenance or preparation for an upcoming Notified Body/FDA inspection.
Verification and Validation
Our quality team's extensive experience in V&V, TMV, etc. methods will ensure your company has the right amount of confidence and reliability in all aspects of operation.
Supply Chain Management / Contract Manufacturers / Contract Designers
Supply chain management continues to evolve in our global network of supply options. Ask how our team can create/support a supplier quality assurance system to ensure suppliers are vetted and held to the level of quality desired.
Design Control and Risk Management
No matter the stage / lifecycle of your products or quality team is ready to support, manage, execute your design, prototyping, small/large lot manufacturing (CMO / CDMO) all with risk management built in.
Change Control / Doc Control / Records Management
Change controls that impact day to day operations are sometimes taken for granted, however, they are a critical aspect of any successful organization. Our team is ready to create, manage, review, and right size a solution to ensure efficiency and minimal burden to the operation.
Coaching / Augmentation / Training
Our team of quality assurance coaches and trainers are ready to execute courses or one on one coaching to support new employees, additional staff, staff transitions or career progression. Additionally, staff augmentation or on the job coaching has also proven successful in many high paced environments.