US-NC-Durham: Sr. Quality Program Manager
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http://sqa.fyicente r.com/jobs/ 99678526_ Sr__Quality_ Program_Manager_ _.html
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Date: 10-Apr-2009
Must have extensive knowledge and experience in implementing the QSR and ISO standards and complex government regulations and procedures with at least 15 years of experience in medical device industry.
Must have broad knowledge of business systems and processes to include, marketing, sales, operations, supplier management, Design Engineering and Quality. Must understand strategy maps, balanced score cards, process mapping and be able to lead teams to achieve results.
Must understand the Baldrige Criteria and business system thinking and concepts and understand how to apply these concepts to improve the business
Must have the ability to work on multiple projects from compliance to business system, process and product improvement.
Possess advance knowledge in multiple specific compliance or business system fields. For example process validation, software validation, statistics, and reliability.
Understand Adult learning concepts and how to apply this to improve overall knowledge of the organization
Excellent written, verbal and computer skills. Must be able to give presentations to all levels and focus on the audience. Must have the ability to effectively present ideas and answer questions from executives, employees, managers, customers, suppliers, lawyers, and FDA and government bodies. Must be able to write reports, business correspondence and procedures that effect multiple functions and business units.
Possess communication and people skills that allows them to communicate and work effectively with senior executives or people on the manufacturing floor
Have the unique skills in creativity in order to solve problems and the ability to work with different cultures in an effective manner.
Must be skilled in project management since some projects last for years. (opening business units, process validation, software validation, CAPA and complaint resolution)
Ability to read analyzes and interprets extremely complex scientific and technical procedures government regulations and professional journals.
Has the knowledge and skill on how to conduct effective system process and compliance audits and assessments.
BS + 17 years of experience or preferred MS degree with 15 years of progressively complex and a variety of quality experience and leadership
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicente r.com