Quality Assurance and Control

Mendell's QA and QC staffs are an unusual bunch of professionals. While their colleagues in Manufacturing and Engineering would grin and offer replies containing phrases such as, "That's true" or "Obviously", further explanation reveals the true nature of their uniqueness.

First, the amount of professional experience in the Quality disciplines is impressive. With an average of almost 19 years, it’s very rare for an unfamiliar challenge to arise, be it measurement systems or process characterization.

The Medical Device and Aerospace manufacturing sectors are the primary sources of this team’s Quality education, training and experience.

Quality Assurance and Control

Process Validation
Risk Management
Investigational Studies
Clean Room Validation
Design, Use and Training
QMS Design and Implementation
ISO 13485:2016 Lead Auditor Certified
Software Development and Validation
Six Sigma Green & Black Belt Training*
Structured Problem Solving
Balanced Scorecard
Failure Analysis
GD&T and Print Reading
Functional Gauge and Fixture Design
Chemical stress analysis

* 2 CSSBB's on staff

Second, the broad range of competencies found in our QA and QC teams are typically only found in much larger companies, such as medical device manufacturers. From Quality Systems integration and compliance, to Process Validation (IQ,OQ,PQ) and Process Improvement, Mendell's Quality Assurance and Control teams are very well versed in the Quality disciplines. Currently, the team has members who hold the ASQ certifications of Certified Manager of Quality and Six Sigma Black Belt.

And lastly, Mendell Quality Control employs the most advanced inspection equipment available. Both contact and visual measurement technologies are effectively utilized in the verification of product conformance.

Major Dimensional Measuring Systems and Software

Zeiss and Bendix CMM
Mycrona and Micro-Vu VMM
2 Optical Comparators (10-100X Mag. Capability)
4 Vertical Height Measuring Systems
Laser Micrometer
2 Height Micrometers
Nikon Tool Scope
Microscopes – many located throughout the shop.
7 Surface Plates
Datamyte Software for Process Control and Capability Analysis
Minitab and QI Macros for Statistical Analyses

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