Quality Systems Audit Specialist

Working under general supervision, ensures compliance with applicable regulatory requirements and St. Jude Medical/CRMD policies and practices. Applies business knowledge and/or principles/methods normally acquired in a recognized four-year course of study. Recommends, interprets and implements St. Jude Medical/CRMD specific policies and procedures to accomplish assignments; resolves a broad range of issues and problems. Identifies and routinely uses the most effective, cost efficient, and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Promotes the process of continuous quality improvement and coordinates solutions for quality system audits. Exercises basic judgment in planning, organizing and performing work; monitors performance and reports status within area of responsibility. Performs special assignments and projects as directed. Assures that quality of services meets internal and external customer requirements. Remains current on developments in field(s) of expertise.Qualifications:A Bachelor’s Degree in the physical or natural sciences, environmental engineering, a related field, or equivalent work experience. Typically a minimum of four plus years of progressively more responsible quality assurance work experience in auditing and medical devices. A demonstrated working knowledge of federal regulations relative to quality systems in a medical device industry. Work requires knowledge of applicable U.S. Food & Drug Administration (FDA) and Technischer Uberwachungsverein (TÜV) regulations as well as related domestic and international quality system audit requirements, and the necessity of working within those constraints. Must have demonstrated written and verbal communication skills (i.e., English grammar and style), interpersonal, presentation, analytical, organizational skills, the ability to interpret basic clinical data, and the ability to meet deadlines as well as the ability to converse effectively with all levels of employees. Must be able to handle multiple assignments. Must be able to perform in a diverse cross-functional team environment. Must have demonstrated basic personal computer skills including a working familiarity with word processing software and relevant regulatory applications. The ability to concentrate on detail and work independently when necessary. Desired Requirements: An advanced credential in a relevant discipline/concentration. APPLY NOW! St. Jude Medical is an equal opportunity employer. We value a diverse workforce across all spectrums, including opinion and experience. We seek out creative, conscientious, confident individuals who thrive on taking initiative. In return for those qualities, we offer outstanding compensation, comprehensive benefits and opportunities for professional growth.