Quality System Specialist- Labeling
About The Position
The Quality System Specialist – Labeling manages the development, maintenance, and controlled implementation of medical device product and packaging labeling to support regulatory compliance, new product development, and production requirements. The role serves as the primary technical resource for labeling processes and systems, coordinates labeling changes across functions, and leads improvements to strengthen accuracy, compliance, and operational efficiency. It also supports regulatory database maintenance, product registration, and other Regulatory Affairs activities according to priorities established by the Quality Systems Manager. The position is part of Quality/Regulatory and reports to the Quality Systems Manager. It is an exempt role. The work is primarily office-based, with occasional interaction with manufacturing or engineering areas. Travel is minimal but may be required for training, audits, or regulatory support. Standard business hours apply, with additional hours or flexibility potentially needed for project deadlines and time-sensitive quality or compliance activities.
Requirements
- Bachelor's degree required.
- Minimum 3–5 years 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 and excellent attention to detail.
- Good interpersonal and organizational skills.
- Ability to apply basic scientific reasoning to resolve technical problems, 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.
- Ability to develop partnerships and influence across organizations.
- General knowledge of medical device regulatory processes and product registration requirements.
- Ability to manage concurrent priorities, maintain accurate controlled documentation, and communicate requirements across functions.
- Ability to follow quality-system procedures, maintain accurate records, verify labeling against approved source information, and identify and escalate errors or compliance risks.
- Ability to work effectively with Regulatory Affairs, Quality, Engineering, Supply Chain, Marketing, and Manufacturing.
- Ability to manage multiple projects and priorities, coordinate across departments, monitor milestones, communicate status, and meet deadlines.
Nice To Haves
- Degree in science, engineering, or a related field.
- Experience using label design and printing software.
- Experience administering labeling systems, supporting ERP interfaces, and performing software validation appropriate to assigned responsibilities.
- Experience with graphic design software.
- Knowledge of medical device capital equipment and sterile/clean-room medical device manufacturing.
- Experience with GUDID, EUDAMED, product registrations, and labeling for sterile devices or capital equipment.
Responsibilities
- Manage assigned medical device labeling activities and work with cross-functional teams.
- Develop, revise, and verify product and packaging labeling against approved product information, applicable regulations, and internal procedures, including 21 CFR Part 801, UDI, EU MDR, and ISO 15223-1.
- Coordinate labeling reviews, approvals, and implementation through established document and change-control processes.
- Partner with Supply Chain and Manufacturing to coordinate label availability, implementation timing, and disposition of obsolete labeling.
- Own labeling software, including coordination of its connection with the ERP system.
- Lead labeling-process improvements and implementation opportunities.
- Investigate labeling errors and technical issues, identify root causes, and implement approved corrective actions.
- Plan, execute, and document assigned labeling verification and validation activities.
- Maintain assigned regulatory databases and product registration activities, such as GUDID and EUDAMED.
- Support Regulatory Affairs submissions, assessments, and information requests according to priorities established by the Quality Systems Manager.
- Collect and prepare documentation required for regulatory submissions.
- Assist with regulatory assessments and implementation of new or changing regulatory requirements.
- Support responses to requests for regulatory documentation and information from internal and external stakeholders.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
