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Quality Systems Technician II

Irving, Texas

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Job ID R0023711

QA tech II- 1st Shift: 6:00am-2:30pm

PURPOSE AND SCOPE: Conducts Quality audits of products assuring company standards are maintained and product integrity is preserved. Consults with management to resolve quality, production, and efficiency problems. Functions as an information source to employees when quality issues occur. PRINCIPAL DUTIES AND RESPONSIBILITIES: • Under general supervision, follows established company policies and procedures and applies acquired job skills to fulfill duties in accordance with requirements of the QSR regulations, the ISO-9001 standard, Corporate and on-site policies and procedures. • Determines whether or not communications regarding company equipment are complaints and whether or not complaints might be reportable to the FDA. • Follows all policies, guidelines, and Standard Operating Procedures (SOP’s) as required. • Prepares quality documentation and reports by collecting, analyzing, and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations. • Develops plans by conducting analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories. • Performs functions that require full knowledge of general aspects of the job. • Works on assignments that are semi-routine in nature, but recognizes the need for occasional deviation from accepted practice. • May provide assistance to lower level staff with more general support tasks that require a better understanding of functions, as directed by immediate supervisor. • Escalates issues to supervisor for resolution, as deemed necessary. • Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations. • Assist with various projects as assigned by direct supervisor. • Other duties as assigned. Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions. PHYSICAL DEMANDS AND WORKING CONDITIONS: • The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • Involves moderately active work involving walking and/or standing for considerable lengths of time. Bending to floor level is required and the employee must be able to routinely lift objects weighing up to 50 lbs as high as 5 ft above floor level. SUPERVISION: • None EDUCATION: • High School Diploma required. • Associate’s Degree or Bachelor’s Degree in Science, preferably in Chemistry or Microbiology desired. EXPERIENCE AND REQUIRED SKILLS: • Minimum 1 – 2 years of related experience. • Field and/or Technical Support Experience with all company equipment preferred. • Understands the clinical application of the equipment. • Familiar with Failure Analysis procedures. • Understands Quality System Regulations and is familiar with FDA regulations for complaint handling. • Effective oral and written communication skills. • Well established computer skills with database, spreadsheet, and word processing programs

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