SQAFYI - Software QA Resource - FYI

US-MD-Elkton: Quality Assurance Associate

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 09-Feb-2009

Quality Assurance Associate

This associate will work on cross-functional teams to address product issues, define and implement effective corrective actions and monitor post-implementation effectiveness. In addition, this associate will focus on operational improvements; product development and design control activities, systems enhancement (including software implementation and validation), compliance auditing, vendor selection and approval, and associate training. Further responsibilities may include: initiation of change documentation; advisory roles supporting various teams (such as raw materials inspection associates, document control, maintenance and calibration, environmental monitoring and control, etc.); preparation of quality reports; review of complaints; and development of policies and procedures which affect operational and compliance status.

Requirements Bachelor's degree in an applicable science or engineering (or a two-year degree plus significant medical device experience or significant medical device experience in a Quality Assurance role). The successful candidate must have at least five years medical device, pharmaceutical, or similarly regulated industry experience in quality assurance or a related role. Additional demonstrated experience in the following areas is also required: •Demonstrated excellent written and oral communication skills •Strong interpersonal skills •Conflict resolution skills •Quality System Regulations •Quality Systems implementation and maintenance. The successful candidate must be able to work independently, as well as part of a diverse team and must possess the ability to set and meet aggressive timelines. Desirable experience includes: working with vendor and process auditing, product/process/software validation, generation of change control documents, document control and receiving inspection. Additionally, familiarity with ERP/MRP, MRS, and quality software systems (e.g., complaint, document control, etc.) is a plus.

To apply for this position, please visit this Website.

Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com

US-MD-Elkton: Quality Assurance Associate