Quality System Specialist- Labeling

About the Company MicroAire Surgical Instruments LLC As a part of the global industrial organization Marmon Holdings — a global industrial organization backed by Berkshire Hathaway you’ll be doing things that matter, leading at every level, and winning a better way. We’re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best. Role Overview The Labeling Specialist manages the development, maintenance and controlled implementation of medical device product and packaging labeling support to regulatory compliance, new product development and production requirements. Serves as the primary technical resource for labeling processes and systems, coordinates labeling changes across functions, and leads improvements that strengthen accuracy, compliance and operational efficiency. Supports regulatory database maintenance, product registration and other Regulatory Affairs activities according to priorities established by the Quality Systems Manager. Quality/Regulatory. Reports to: Quality Systems Manager. Exempt. Essential Duties and Responsibilities Manages assigned medical device labeling activities and works with cross functional teams Develops, revises, and verifies product packaging labeling according with approved product information, applicable regulatory requirements and internal procedures, including applicable requirements related to: 21 CFR Part 801 (Medical Device Labeling) UDI (Unique Device Identification) EU MDR (Medical Device Regulation) ISO 15223-1 (Medical Device Symbols) Coordinate labeling reviews, approvals and implementation through established document and change control Partner with Supply Chain and Manufacturing to coordinate label availability, implementation timing, disposition of obsolete labeling Owner of labeling software including coordination of connection with ERP system Lead labeling process and implementation of opportunities for improvement for labeling Investigate labeling errors and technical issues, identify root causes and implement approved corrective actions Plan, execute and document assigned labeling verification and validation activities in accordance with approved activities Maintain assigned regulatory database and product registration activities (e.g. GUDID, EUDAMED) Support Regulatory Affairs submissions, assessments and requests for information according to priorities established by the Quality Systems Manager, including: Supporting collection and preparation of documentation required for regulatory submissions; Assisting with regulatory assessments and implementation of new or changing regulatory requirements; Supporting responses to requests for regulatory documentation and information from internal and external stakeholders Perform other duties as assigned Education and Experience Bachelor's Degree required, preferably in science, engineering or related field. Minimum 3-5 years’ experience of relevant medical device labeling experience, including controlled labeling changes and use of label design or printing systems. If this is intended as a senior role, consider a five year minimum and require demonstrated independent process or system ownership. Working understanding of regulatory and quality requirements applicable to medical device labeling, including FDA requirements, EU MDR, Health Canada requirements, ISO 13485 and other applicable global requirements. Good verbal and written communication skills; excellent attention to detail. Good interpersonal and organization skills; attention to detail. Judgement: Ability to apply basic scientific reasoning to resolve technical problems. Ability to interpret technical information, evaluate labeling discrepancies and resolve issues within established authority. Good project management skills. Proficiency in Microsoft Office and other job associated software. Demonstration of an ability to develop partnerships and inter-organization influence skills. Knowledge of medical device capital equipment sterile/clean room medical device manufacturing. Experience using label design and printing software; experience administering labeling systems supporting ERP interfaces and performing software validation appropriate to assigned responsibilities and/or graphic design software is a plus. General knowledge of medical device regulatory processes and product registration requirements required. Execution and communication: Demonstrated ability to manage concurrent priorities, maintain accurate controlled documentation and communicate requirements across functions. Preferred: Experience with GUDID, EUDAMED product registrations and labeling for sterile devices or capital equipment, as applicable to the product portfolio. Competencies Quality & Compliance Maintains rigorous standards to ensure labeling documentation and processes comply with quality system and regulatory requirements. Applies quality system controls to maintain accurate compliant and traceable labeling. Reviews labeling content for accuracy, completeness, and regulatory compliance. Ensures labels meet FDA EU MDR Health Canada ISO 13485 UDI and other applicable requirements. Identifies compliance risks and escalates issues appropriately. Maintains accurate records and controlled documentation. Consistently follows established quality system procedures and requirements. Verifies labeling against approved source information; follows review, approval and change control requirements; maintains complete records; identifies and promptly escalates errors or compliance risks. Technical & Regulatory Expertise Applies specialized medical device labeling labeling system capabilities and regulatory knowledge to support business objectives and compliance requirements. Demonstrates expertise in medical device labeling regulations and standards. Interpret/translate new or changing regulatory requirements and translates them into labeling updates. Supports regulatory databases and product registration systems such as GUDID and EUDAMED. Provides technical guidance related to labeling requirements and regulatory expectations. Maintains current knowledge of global regulatory developments affecting labeling. Continuous Improvement Identifies opportunities to improve processes, systems and operational effectiveness. Evaluates existing labeling processes and recommends enhancements. Leverages data and feedback to improve efficiency and reduce errors. Leads implementation of labeling system improvements. Supports automation and integration opportunities between labeling software and ERP systems. Promotes best practices that improve compliance, quality and productivity. Building Collaborative Relationships Develops effective partnerships with internal and external stakeholders to achieve shared goals. Works effectively with Regulatory Affairs Quality Engineering Supply Chain Marketing and Manufacturing. Communicates labeling requirements clearly to stakeholders. Builds credibility as a subject matter expert for labeling compliance. Responds professionally to requests for documentation and regulatory information. Influences cross-functional teams to support compliant and effective labeling solutions. Analytical Problem Solving Uses critical thinking technical knowledge and sound judgment to resolve issues and make recommendations. Analyzes labeling issues to determine root causes and appropriate solutions. Evaluates regulatory requirements when making labeling decisions. Assesses the impact of proposed changes on compliance and operations. Supports investigations and validation activities with fact based analysis. Makes well reasoned recommendations using available data and regulatory guidance. Planning & Execution Effectively organizes work manages priorities and delivers results in a timely manner. Manages multiple labeling projects and priorities simultaneously. Delivers labeling updates to support production schedules and new product launches. Coordinates activities across departments to ensure project completion. Monitors project milestones and communicates status updates. Follows through on commitments and meets established deadlines. Work Environment, Physical Demands and Protective Equipment This position operates primarily in an office environment with minimal physical demands. Work involves regular use of computers and standard office equipment. Occasional interaction with manufacturing or engineering areas may be required. Must be able to remain stationary for extended periods and perform repetitive tasks such as typing and document review. All required personal protective equipment (PPE) must be worn when entering designated areas in accordance with company safety procedures and departmental requirements. Schedule, Travel Responsibility, Special Conditions or Requirements This is a full-time position with standard business hours additional hours may be required to meet project deadlines or support business needs. Travel is minimal but may be required for training audits or regulatory support activities. This role may require flexibility to support audits regulatory submissions system implementations or other time-sensitive quality and compliance activities. Pay Range $70,000-$95,000 Equal Opportunity Employer We are an equal opportunity employer and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process please email your request to View email address on click.appcast.io and please be sure to include the title and the location of the position for which you are applying. About Marmon Welcome to the biggest small business you’ll ever find. Part of Berkshire Hathaway Marmon is a global industrial organization made of 11 industry groups with 30K employees and $12 billion in annual revenue. As leaders in their respective industries our 120+ companies thrive on an independent mindset and entrepreneurial spirit. At the same time they benefit from being part of our industry groups where they’re able to tap into the expertise and insights of other Marmon companies. While we’re all unique we all share a common commitment to doing things that matter leading at every level and winning a better way. When you work at Marmon you’re advancing our everyday world and beyond. Our engineering solutions help millions around the world stay connected healthy and safe. Wherever you’re at in your career our people and resources will help you go further. As you grow your skills you can also move up and around our 120+ companies. Work at a place you can stand behind. We show up to win every day uphold the highest ethical standards and always look to put each other in the best position to win. #J-18808-Ljbffr MicroAire Surgical Instruments LLC