|
I. Job Purpose and Core Tasks This role will test audio/visual components according to established SOPs, follow process and quality system protocol, assist in production and assembly operations, inspection of parts and components, while adhering to cost controls and workflow requirements, comply with documentation requirements, assist in other facility functions, and all general QC requirements for the operation as required by the FDA. Primary functions: * Perform incoming inspection of raw materials/components. * Perform functional testing for pass/fail results. * Perform electrical safety testing of various products. * Perform visual QC inspection and responsible for final product labeling * Ensure all tests are performed according to established item specifications, standard test methods, or protocols. * Interpret test results, compare them to established specifications, and make recommendation on appropriateness of data for release. * Investigate or report questionable test results. * Identify quality problems and recommend solutions. * Responsible for maintaining a current and thorough knowledge of industry standards and best practices. * Responsible for creating positive and professional image of KSEA when communicating with others. * Ongoing communication with multiple departments, divisions and various management personnel. * Help design and integrate testing modules for new products. * Perform configuring of software / firmware to components. * Perform disinfection wipe downs of returned field products when applicable. * Perform schedule preventative maintenance of testing equipment. * Monitor and keep current devices which require calibration. * Monthly reporting as related to Quality metrics * Able to write and update work instructions In Microsoft Word documents. * Performs other job-related duties or special projects as assigned. II. Minimum Knowledge, Education and Skill Requirements Required Minimum years of relevant work experience: * 2-4 years' experience Minimum education, certifications and/or credentials: * High school diploma or (GED), some college or vocational school preferred. Minimum hard skill requirements (including computer and application proficiency): * Microsoft Office such as Word and Excel etc. * Able to read schematic and system design drawings. * Solid knowledge of audio and visual connectivity and signal flows. Minimum soft skill requirements: * SAP program * Understand manufacturing processes * Work in an ESD environment. Preferred Preferred years of relevant work experience: * 2-4 years Preferred education, certifications and/or credentials: * A/V and IT related courses and certifications. Preferred hard skill requirements: * Competency in QC related tasks, such as AV design and testing / GMP. * ESD Environment experience. * Excellent planning, organizing and problem-solving skills. * Read and understand schematic and system drawings. * Solid knowledge of audio and visual connectivity and signal flows. * Upgrading of software and firmware files to products. * Use of computer and working with SAP system. * Working with ESD components. Preferred soft skill requirements: * System evaluation, testing, good documentation and reporting skills. * Understand and follow workflow processes. III. Essential Function Must be able to maintain productive working relationships and treat fellow employees with respect. Has contact with: Production Operations and other departments. Physical requirement/Demands: Frequent standing and sitting. Lift up to 50lbs at times Manual dexterity for computer and electronic work. Mental requirements/Emotional Demands: Must be able to work cooperatively in a team-oriented environment. Must be able to work under pressure at times to meet strict deadlines. Open to new ideas and being creative. Interpersonal and communication skills: Good verbal and written skills Technical problem solving IV. Core Requirements Degree of accountability: Will work under frequent supervision Degree of decision making: Will work in specialized tasks and limited variety of tasks. Financial/Budgetary: None Safety: Adhere to KARL STORZ Safety protocols Quality: Adhere to KARL STORZ Quality Management System Supervision: Does not supervise others Authority to Sign (not applicable for North America): None Travel: N/A
|