My client is a 60 year old company. They were one of the first to bring dialysis treatment out of the hospitals and into the free standing clinics that we see today. They have over 1500 clinics nationwide.
Over the past 20 years they have branch out into the medical device and pharmaceutical area and have marketed products used for dialysis treatment. They now have 4 manufactures plants of there own; 2 in the US 1 in Mexico and 1 in Canada. This is a great opportunity to work with both pharmaceutical and medical device products.
The exciting part of working for this company is that have tremendous resources available to them, they have recently purchased and NDA and they have a plan for continued growth.
They are looking for a Quality Systems Auditor/Trainer to be based in at their North American Headquarter in Waltham MA. There would be about 40% travel involved and it would be a mix of auditing as well as doing training on quality systems as various locations.
If you have a the following background, we should talk! 207-510-6666 ext 122
BS/BA in Engineering, Life Sciences, Quality Management, or significant work experience providing a knowledge base is required.
3-5 years quality system auditing experience in a medical manufacturing environment.
5-7 years working in quality assurance in a medical products manufacturing environment.
Working knowledge of the requirements of 21 CFR 820, 21 CFR 211, and ISO 13485:2003 (knowledge of Canadian and Mexican regulations desired).
Able to travel 40% international and domestic