Quality System Specialist-Labeling

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 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. 
• 3 years plus experience of relevant medical device labeling experience, including controlled labeling changes and use of label design or printing systems.

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.
• undefined

+ Competencies

 Quality & Compliance  

Skills: 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.

Behaviors:

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-  

Skills: Applies specialized medical device labeling, labeling system capabilities and regulatory knowledge to support business objectives and compliance requirements.

Behaviors:

•  Demonstrates expertise in medical device labeling regulations and standards.
• Interpret\translates 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

Skills:  Identifies opportunities to improve processes, systems, and operational effectiveness.

Behaviors:

•  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:

Skills: Develops effective partnerships with internal and external stakeholders to achieve shared goals.

Behaviors:

• 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

Skills: Uses critical thinking, technical knowledge, and sound judgment to resolve issues and make recommendations.

Behaviors:

•  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-  

Skills: Effectively organizes work, manages priorities, and delivers results in a timely manner.

Behaviors:

•  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

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.

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 [email protected], and please be sure to include the title and the location of the position for which you are applying.