Certification
Description
Education/Experience*
Understands the principles of standards, regulations, directives and guidance for auditing a biomedical system
Tests, calibrates, maintains and repairs electrical, mechanical, electromechanical, analytical and electronic measuring, recording and indicating instruments and equipment for conformance to established standards.
Uses various tools and techniques to examine, question, evaluate and report on that system's adequacy and deficiencies.
Facilitates and leads team efforts to establish and monitor customer/supplier relations, and supports strategic planning and deployment initiatives.
The target audience for the ASQ MBB certification are candidates that are or have been employed as MBBs within their organization, or well qualified SSBB's that have substantial experience in each of the major topic areas within the Portfolio.
1) At least 5 years of experience in the role of a SSBB or MBB.
OR
2) Completion of 10 Six Sigma Black Belt projects.
Understands the GMP principles as regulated and guided by national and international agencies for the pharmaceutical industry.
Analyzes all elements of a quality system and judges its degree of adherence to the criteria of industrial management and quality evaluation and control systems.
Develops and operates quality control systems. applies and analyzes testing and inspection procedures. Uses metrology and statistical methods to diagnose and correct improper quality control practices.
Understands quality tools and their uses and participates in quality improvement projects.
Two years of work experience or an associate degree as a minimum.
Evaluates hardware documentation, performs laboratory procedures, inspects products, measures process performance, records data and prepares formal reports.
Two years of on-the-job experience in mechanical inspection or a related field. A high-school diploma or GED, or an additional three years of related on-the-job experience.
Analyzes and solves quality problems and participates in quality improvement projects.
Two years of work experience or an associate degree as a minimum.
Prepares inspection plans and instructions, selects sampling plan applications, analyzes and solves problems, prepares procedures, trains inspectors and performs audits.
Understands the principles of performance evaluation and prediction to improve product/systems safety, reliability and maintainability.
Understands Six Sigma philosophies and principles, including the supporting systems and tools. Demonstrates team leadership and understands all aspects of the DMAIC model in accordance with Six Sigma principles.
Two completed projects with signed affidavits, or one completed project with signed affidavit and three years of work experience in one or more areas of the
Six Sigma Black Belt Body of Knowledge. You do NOT need to be a Certified Six Sigma Green Belt.
Supports a Six Sigma Black Belt by analyzing and solving quality problems and is involved in quality-improvement projects.
The Six Sigma Yellow Belt Certification is aimed at those new to the world of Six Sigma who have a small role, interest, or need to develop foundational knowledge. Yellow belts can be entry level employees that seek to improve their world or executive champions who require an overview of Six Sigma and DMAIC.
Understands software quality development and implementation including software inspection, testing, verification, and validation. Implements software development and maintenance processes and methods.