Job Description Position Summary The Labeling Manger oversees all activities related to device labeling. Ensures requirements for labeling are met while maintaining compliance with regulatory and manufacturing regulations. In addition, the Labeling Manager will represent the Configuration department as a labeling subject matter expert. Essential Duties & Responsibilities * Manage all aspects of the labeling department employees and responsibilities providing performance feedback, evaluations, developmental coaching, and staffing plans. * Lead in the development of strategic initiatives including departmental goals, labeling systems and content management. * Maintain the smooth and efficient operation of the labeling group * Oversee the correct, complete, and compliant execution of product labeling * Develop and maintain labeling procedures that comply with FDA, GMP, ISO and other applicable standards and regulations * Understand and monitor label team participation in change control * Assure department activities comply with establish SOPs, best practices, and GMPs. * Assure all employees are properly trained and the training is correctly documented * Develop new processes which support speed, cost reductions, and process improvements. Optimize existing processes to maximize efficiency. * Resolve problems and exceptions * Optimize existing processes to maximize efficiencies and continue to identify, plan and execute continuous improvement initiatives * Drive continuous improvements through observation, measurement and root cause analysis/resolution * Manage personnel performance by providing performance feedback, evaluations,and developmental coaching. * Derive and present key performance indicators (KPIs) * Represent the labeling team as a super user/subject matter expert, on company teams, and as a resource for other departments. Coordinate activities with other supply chain departments. * Maintain and document label data storage and utilization * Develop and maintain tools to manage label team workflow * Manage labeling group budget * Work on special assignments as they arise Knowledge & Skills * Excellent organizational and interpersonal skills required. * High level of attention to detail * Excellent verbal and written communication skills * Ability to demonstrate proficiency in issue resolution. * Ability to manage complicated tasks in a high pressure, fast paced environment. * Ability to multi-task and work with little direction. * Ability to delegate and manage multiple priorities. * Advanced knowledge of FDA regulations, CGMP's, and ISO standards regarding product configuration * Subject matter expert on labeling regulations and guidelines * Knowledge and experience with pharmaceutical product labeling * Proficient in Excel, Word, and Outlook * Technically proficient with computer software programs, i.e. ERP systems, experience with specific programs relevant to this position Minimum Qualifications, Education & Experience * Must be at least 18 years of age * Bachelor's degree from an accredited college or university is required * Minimum 10 years of direct work experience in a medical device manufacturing company * Minimum 5 years of experience in a documentation environment that includes authoring, processing and control of procedures * ERP experience required, strong computer skills required, working knowledge of MS Office, strength in Excel. Work Environment * This is largely a sedentary role. * This job operates in a professional office environment and routinely uses standard office equipment. * Typically requires travel less than 5% of the time About Us ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges. With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings. We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you: * Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization. * The industry's broadest IV smart pump offering covering large volume, pain management, and ambulatory needs. * IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company. * Significant US IV solutions manufacturing and supply capabilities. This role is based remotely; the incumbent may be remote in any state other than Colorado; California; Connecticut; Montana, Maine or New York. ICU Medical EEO Statement: ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status. If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at [email protected]. We are committed to providing equal access and opportunities for all candidates. ICU Medical EEO Policy Statement Know Your Rights: Workplace Discrimination is Illegal Poster ICU Medical CCPA Notice to Job Applicants
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