at ICU Medical in Lake Forest, Illinois, United States
Job Description
Job Title Specialist III, Quality Systems FLSA Status Exempt Position Summary The Specialist III, Quality Systems reports directly to the Quality Systems Manager. This position will support various subsystems with the Quality System for ICU Medical. This position will work on a variety of QMS subsystems to establish the procedural and training framework and focusing on QMS harmonization, functional activities associated with document and record control, and support in the coordination of Executive Management Review. This position will also be responsible for reviews and formatting of draft documents, procedures, and records. The position will complete projects with peer input and guidance from management for innovative and continuous quality improvement of processes that promote customer satisfaction and service, while maintaining regulatory compliance. The position will work closely with Regulatory, Commercial, Research & Development, Engineering, Manufacturing and other Quality functions to assure QMS requirements are met. Essential Duties & Responsibilities – Plans, organizes and conducts technical projects for ICU Medical sites and monitoring for alignment of overall quality systems architecture across ICU Medical manufacturing sites, regions and functions. – Supports quality system integration and harmonization activities for the ICU Medical Quality Management System, while ensuring compliance with the US FDA Quality System Regulations (21CFR820, 210, 211), ISO 13485:2016, EU MDD/MDR, International Standards and other regulations, as required. – Review documentation to quality standards. – Works collaboratively with teams to ensure awareness of regulatory requirements and environments to develop appropriate strategies for technical projects, including training. – Perform or support periodic audits (planned or unplanned). – Participate in process improvement efforts. – Review and revise departmental operating procedures as required. – Maintain distribution to satellite files. – Leads the data gathering, preparation and execution of Executive Management Review. – Provide training, system support, and quality system rules for employees. – Work on special projects as they arise. Knowledge, Skills & Qualifications – Ability to complete advanced projects with minimal guidance from managers. – Advanced level of expertise in field of expertise and familiar in other areas of expertise within the team. – Ability to apply complex procedural requirements to an electronic document management system. – Holistic understanding of the big picture strategy and can recommend solutions to critical issues. – Ability to think critically and independently make decisions that impact the attainment of project objectives. – Understanding of product structure and role of product specifications, drawings, bills of material, and general procedures. – Previous experience with electronic document management system and ERP system such as Oracle EBS. – Previous experience supporting documentation systems including, but not limited to the following: product specifications, drawings, inspection documents, Bill of Materials (BOM) maintenance, and file maintenance. – Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration. – Experience using Microsoft Word, Excel, PowerPoint, and Adobe Acrobat Professional – Familiarity with cGMP, FDA, and guidelines governing medical devices. – Brings substantive conflicts and disagreements into the open and attempts to resolve them collaboratively; builds consensus. – Strong organizational, communication and people skills. – Strong verbal and written communication skills. – Excellent attention to detail. Education and Experience – Bachelor’s Degree from an accredited college or university (business, teaching, science/biology) – 4-7 years of experience required, preferably in a regulatory, quality or compliance position Minimum Qualifications – Must be 18 years of age Travel Requirements – Typically requires travel 10-15% of the time Physical Requirements and Work Environment – This is largely a sedentary role – This job operates in a professional office environment and routinely uses standard office equipment ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Title: Specialist III, Quality Systems (Hybrid) Location: IL-Lake Forest Requisition ID: 24300174
