QA Specialist, Class I and II medical devices

Image Stream Medical (ISM) designs, manufactures, and markets visualization and image management solutions for the Operating Room and special procedure clinics. Establishing a track-record of innovation, ISM introduced the first DVD burning surgical video recorder, video editing software for physicians that integrates with Power Point, simultaneous dual source recording capability, and now video-over-IP streaming from the OR. Our focus has provided us with the knowledge and expertise necessary to lead the way in digital image visualization and management solutions--now and into the future.

 

 

We are seeking an experienced Quality Assurance Specialist to ensure compliance to U.S. and International medical device complaint reporting requirements; manage customer complaints for all existing and new product lines;  manage CAPA process and reporting; plan, schedule and perform internal audits; and maintain awareness and knowledge of FDA, MDD, CSA and other applicable quality requirements. This person will be a problem solver, change agent, and quality advocate in a positive way.  

 

Ideal candidates will have a BA/BS and 3-5 years experience in the medical device industry with minimum of 2 years experience in QA handling complaints, CAPA and/or MDR/MDV reporting required.  Audit experience required and certification a significant plus.  Must have computer and database management strength, good communications and motivational skills, superb attention to detail and project management, and ability to be self-directed. Demonstrated leadership in process improvement initiatives is a plus. Knowledge of CE marking and 60601 requirements preferred.  Strong work ethic, high energy, â€�do what it takes to get the job doneâ€� attitude along with good organizational and communications skills are essential to be successful here.

 

Image Stream Medical is embarking on an aggressive expansion of our leading edge product lines and further developing our teams of energetic professionals.  You can be part of this growth stage while sharing in the excitement and rewards. 

 

If you’re looking for a small company with growth opportunity, great colleagues, and a stimulating work environment where you can make a difference, forward your resume to careers@imagestreammedical.com

 

Image Stream Medical, One Monarch Drive, Littleton, MA 01460

www.ImageStreamMedical.com

 

 

 

Note to Employment Agencies: Please do not forward any agency resumes. Image Stream Medical is not responsible for any fees related to resumes that are unsolicited.

 

ISM will only accept job applications from candidates who are properly documented with authorization to work in the United States.