QES specializes in consulting, development and operation of quality systems for the medical and consumer industries with a primary focus on design and development and manufacturing. We offer complete QE solutions by means of our services such as Validations (IQ, OQ, PQ), Internal Quality System Audits, Implementation of Quality System to achieve FDA and ISO Compliance, Hands-on Assistance to obtain ISO Certification, Quality Plans, SPC Set Up and Management, Support of New Products Introduction-from Design to Manufacturing, Supplier Quality Engineering, Calibration & Gage Management-from Purchasing to Calibration, Training & Seminars, QE Recruitment, among others.
We are a FDA and ISO compliant engineering consultants with extensive experience delivering quality engineering support to high regulated and demanding industries. QES offers a variety of services that will help you to achieve your business goals. When working with us you will get excellent industry knowledge and customer support.
Let's make it happen! Contact us today to set up a complimentary consultation.
Upcoming Seminar- Register Now!
“How to obtain ISO 13485 certification and FDA QSR 21 part 820 compliance”
When
Date: Wednesday, Sept. 7 th, 2011
Time: 3:30 - 7:30 PM
Joint us to discover the exciting world of quality assurance and regulatory compliance. This
is the opportunity for you to become knowledgeable about the quality standards for the medical
device industry. Obtain the power to lead the ISO 13485 certification process of your
workplace as well as to accomplish the compliance with FDA QSR. This capability will
make you a more competitive professional who is able to implement a quality management
system in the medical device industry as well as in other fields.
What is ISO 13485?
International Standards Organization (ISO) 13485 – Quality Management System (QMS) for
medical devices. This is essentially ISO 9001 tailored for medical devices.
What is FDA QSR 21 part 820?
The US government Code of Federal Regulations (CFR) Title 21, part 820 – The Quality
System Regulation (QSR). This also commonly known as Good manufacturing Practices
Seminar Cost: $295
Where:
Quality Engineering Solution – QES
400 Trade Center, Suite 5900
Woburn, MA 01801
Light refreshment will be served!!
Who should attend?
Quality Engineering Professionals - This seminar will reinforce one the basis of a Quality
Engineering Role. It is critical that QE’s have a deep understanding of the industry standards
so they can coach and support to accomplish the compliance of their workplace.
R&D, Manufacturing and Engineering Professionals - This seminar will help them to improve
their understanding of the industry standards, from the quality standpoint, so they can
be effectively applied to their specific duties.
Technical Discipline Professionals – You’ll get more familiar with the standards of the
medical device industry. This seminar will help you to perform your job better as it makes
you knowledgeable about the application of a quality system in your workplace.
Technical Discipline Students - This is a great opportunity for you to get familiar with the
medical device industry standards. This will make you a more competitive candidate for a job
opportunity.
Non-Medical Device Industry Professionals - Most of the principles of the medical device
industry standards could be applied to other industries to achieve a good quality system for
your workplace. This seminar will help you to know the tools available for you to assure
quality in your company.
To register please visit our website www.qescompany.com and go to the “contact us” tab;
enter your registration information, specifying seminar code 2011-020. Once this is received
you’ll get a pre-filled-out registration form via e-mail within 48 hours for you to return with
your payment. Once the payment is received you’ll receive an e-mail with your training pass
for the event.
For additional information, write to us at
