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 Salary Range - $97,500 - $139,750 The salary range displayed represents the annual base salary we reasonably expect to pay for this role. The actual salary may vary [differ] based upon various factors, including, but not limited to, relevant experience, skills, education, licensure/certifications, and geographic location. ICU Medical provides a comprehensive total rewards package that includes: * Competitive financial benefits, including a generous 401(k) match and (for eligible roles) our Annual Incentive Plan * A wide range of benefit options at affordable rates * Additional perks to assist employees with their work-life effectiveness, such as Paid Time Off, Company Holidays, and Tuition Reimbursement Additional information on health and welfare benefit offerings can be found at https://www.icumed.com/about-us/careers/investing-in-your-future/.
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