Quality System Specialist- Labeling

Marmon Holdings; Charlottesville (VA); On-site; USD 85,000 - 110,000; Full time

Job summary

MicroAire Surgical Instruments LLC is seeking a Labeling Specialist to lead development, maintenance and controlled implementation of medical device labeling across product lines, ensuring regulatory compliance from design through production.

You will partner with Regulatory Affairs, Quality, Supply Chain and Manufacturing to coordinate labeling changes, document control, ERP integration and system validation, supporting GUDID/EUDAMED as needed.

Qualifications

• Bachelor's degree in science or engineering required.
• 3–5 years of medical device labeling experience.
• Knowledge of FDA labeling requirements and ISO 13485.

Responsibilities

• Manage labeling activities and coordinate reviews across functions.
• Develop and verify product packaging labeling per regulations.
• Maintain labeling software and ERP interface coordination.
• Support regulatory submissions and product registrations.
• Investigate labeling issues and implement corrective actions.

Skills

Attention to detail

Regulatory compliance

Project management

Documentation

Communication skills

MS Office

Education

Bachelor's Degree in science or engineering

Tools

Labeling software

ERP interfaces

Graphic design software

Job description

MicroAire Surgical Instruments LLC

As a part of the global industrial organization Marmon Holdings-which is 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.

The Labeling Specialist

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 ma