US-MA: Quality Assurance Specialist
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Quality Assurance Specialist III
Responsibilities include conducting internal organizational audits as well as conducting external supplier audits in support of projects in development. Responsible for facilitating training to various groups within the organization. Will lead or participate in a team environment to establish goals, priorities, and decision-making. Responsible for assisting in the development, validation and improvement of new products. Responsible for assisting in the development, implementation and improvement of quality principles and tools including statistical methodologies and process improvements. Responsible for advising project teams in product and process development and problem solving methods in scientific disciplines.
A minimum of a Bachelors degree in Scientific or related field is required, with an advanced degree preferred. A minimum of 6 years experience in Quality within the Medical Device and/or Pharmaceutical industry is required. Knowledge and hands on experience with all elements of standards applicable to medical device, biologics and/or pharmaceutical design and manufacturing is required. Knowledge and experience with IBM compatible computer software including Word, Excel, Power Point and Access is required. Strong leadership skills with the ability to identify solutions to business problems will be required. Excellent communication with demonstrated track record in fostering collaboration and building consensus to achieve collective objectives will be required. Excellent written and oral communication and interdependent partnering skills are needed.
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Team SQAFYI - Software QA Resource FYI