Job Summary
We are seeking a highly experienced Senior Labeling Quality Engineer / Labeling Quality SME with 10+ years of relevant experience in the medical device industry. The role involves providing senior-level quality and compliance oversight for medical device labeling activities, ensuring that product labels, Unique Device Identification (UDI) codes, Instructions for Use (IFUs), packaging inserts, artwork, symbols, warnings, and associated documentation comply with applicable global regulatory requirements and quality standards. The ideal candidate will have extensive hands-on experience with medical device labeling, FDA 21 CFR Part 801, EU MDR, ISO 13485, ISO 14971, UDI requirements, artwork and change control, labeling and printing process validation, CAPA, non-conformance investigations, and regulatory audit support. This is a senior hands-on role requiring independent management of complex labeling quality activities and cross-functional collaboration.
Key Responsibilities
• Serve as a senior Quality Subject Matter Expert (SME) for medical device labeling and associated regulatory requirements.
• Review and approve product labels, IFUs, packaging inserts, artwork, and other labeling documentation for compliance with applicable regulations and standards.
• Ensure compliance with FDA 21 CFR Part 801, EU MDR, ISO 13485, and other applicable global medical device labeling requirements.
• Verify that labels contain all required information, including UDI-DI and UDI-PI, lot and batch numbers, serial numbers where applicable, manufacturing and expiration dates, regulatory symbols, warnings, precautions, and storage and handling information.
• Ensure labeling information is accurately presented in both human-readable and machine-readable formats.
• Assess regulatory and quality impacts of proposed labeling changes.
• Provide subject matter expertise for Unique Device Identification (UDI) requirements.
• Review and verify UDI-DI/UDI-PI information and associated barcode content.
• Ensure consistency of UDI and product information across labels, packaging, IFUs, artwork, technical documentation, and applicable systems.
• Support labeling requirements across multiple products, packaging levels, and global markets.
• Investigate and resolve UDI and labeling data discrepancies.
• Review, approve, and control changes to product labeling artwork, IFUs, packaging inserts, and related documentation.
• Manage labeling changes through established change control and document control procedures.
• Ensure appropriate review, approval, version control, and traceability throughout the labeling lifecycle.
• Support labeling changes associated with product modifications, regulatory updates, new product introductions, and market expansions.
• Ensure obsolete artwork and labeling versions are appropriately controlled.
• Partner with R&D, Human Factors, Regulatory Affairs, and Quality teams to ensure product labeling appropriately reflects identified product risks.
• Ensure warnings, precautions, contraindications, instructions, and symbols align with ISO 14971 risk management documentation.
• Review labeling for effective hazard communication and usability.
• Ensure labeling changes resulting from risk assessments, post-market surveillance, complaints, or CAPAs are appropriately implemented.
• Provide Quality oversight and support for validation of labeling, marking, and printing processes.
• Support validation activities involving laser marking, thermal transfer printing, flexographic printing, barcode printing and verification, and automated labeling systems.
• Verify compatibility and performance of inks, ribbons, substrates, label materials, printing equipment, and barcode scanners.
• Ensure barcode readability, print quality, durability, and scanner compatibility meet applicable requirements.
• Review and approve validation protocols, test results, deviations, and validation reports related to labeling processes.
• Lead complex investigations involving labeling errors, mislabeling events or escapes, incorrect artwork, UDI/barcode failures, printing defects, and labeling-related customer complaints.
• Perform or lead structured root-cause analysis to determine underlying causes of labeling quality issues.
• Develop and implement appropriate Corrective and Preventive Actions (CAPA).
• Support CAPA effectiveness verification and ensure sustainable resolution of identified issues.
• Evaluate labeling non-conformances for product quality, patient safety, regulatory, and compliance impact.
• Identify recurring trends and drive systemic improvements to labeling processes.
• Ensure all labeling activities comply with established Quality Management System (QMS) requirements.
• Provide Quality oversight for labeling-related change controls, document controls, deviations, CAPAs, non-conformances, and validation activities.
• Maintain appropriate traceability and objective evidence throughout the labeling lifecycle.
• Drive continuous improvement initiatives to strengthen labeling quality and compliance processes.
• Maintain labeling documentation and compliance records in an audit-ready state.
• Act as the Labeling Quality SME during FDA inspections, Notified Body audits, ISO 13485 audits, and internal quality audits.
• Respond to labeling-related auditor questions and provide supporting objective evidence.
• Support investigation and remediation of labeling-related audit observations and findings.
• Ensure timely closure of corrective actions resulting from audits and inspections.
• Provide senior-level technical and quality guidance on complex medical device labeling matters.
• Collaborate with Quality, Regulatory Affairs, R&D, Human Factors, Manufacturing, Packaging Engineering, Supply Chain, Operations, and other stakeholders.
• Lead labeling quality reviews, risk assessments, investigations, and compliance discussions.
• Provide guidance and mentoring to junior Quality Engineers and other team members.
• Identify labeling quality risks early and drive appropriate mitigation and escalation.
Required Qualifications
• 10+ years of overall relevant experience, with significant hands-on experience in Quality Engineering and medical device labeling.
• 7+ years of experience within the medical device industry is mandatory.
• 5+ years of hands-on experience with medical device labels, UDI, IFUs, packaging inserts, and artwork.
• 3-5 years of strong knowledge of FDA 21 CFR Part 801 and associated medical device labeling requirements.
• 3-5 years of strong working knowledge of EU Medical Device Regulation (EU MDR).
• Strong knowledge and practical application of ISO 13485.
• Experience applying ISO 14971 risk management principles to medical device labeling.
• Strong practical knowledge of UDI-DI, UDI-PI, barcode requirements, and machine-readable labeling information.
• Demonstrated experience with artwork lifecycle management, document control, and change control.
• Hands-on experience supporting labeling and printing process validation.
• Strong experience with CAPA, non-conformance investigations, root-cause analysis, and complaint investigations.
• Demonstrated experience supporting FDA inspections, Notified Body audits, and/or ISO 13485 audits.
• Strong analytical and problem-solving capabilities with exceptional attention to detail.
• Ability to independently lead complex labeling quality activities and operate as a senior SME.
• Strong communication skills and the ability to work effectively across global and cross-functional teams.
Preferred Qualifications
• Experience supporting global medical device portfolios across the US, EU, and other regulated markets.
• Knowledge of GS1 and/or HIBCC barcode and identification standards.
• Experience with UDI databases and regulatory data management.
• Experience with electronic artwork management, document management, and Quality Management Systems.
• Experience with large-scale labeling remediation, UDI implementation, or regulatory compliance programs.
• Experience supporting new product introductions and global product launches.
• Experience with Class II and/or Class III medical devices.
• Previous experience functioning as a Labeling Quality Lead or SME within a medical device organization.
Key Skills
• Medical Device Labeling Quality, UDI, IFUs, Artwork, FDA 21 CFR Part 801, EU MDR, ISO 13485, ISO 14971, CAPA, Labeling and Printing Process Validation, Change Control, Document Control, Non-Conformance Investigations, Root-Cause Analysis, Regulatory Compliance, Audit Support, and Quality Management Systems.
Critical Screening Criteria
• 10+ years of relevant Quality/Labeling experience.
• Direct medical device industry experience is mandatory.
• Hands-on medical device labeling quality experience is mandatory.
• Experience with product labels, UDI, IFUs, packaging inserts, and artwork.
• Knowledge of UDI-DI/UDI-PI and barcode compliance.
• Experience with FDA 21 CFR Part 801, EU MDR, ISO 13485, and ISO 14971.
• Experience with artwork lifecycle management, document control, and change control.
• Experience with labeling and printing process validation.
• Experience with CAPA, non-conformance, and root-cause investigations.
• Experience supporting FDA, Notified Body, and ISO 13485 audits.
Ideal Candidate Profile
The ideal candidate is a senior, hands-on Medical Device Labeling Quality Engineer / SME who has directly owned or supported labeling quality activities involving UDI, IFUs, artwork, labeling compliance, printing and label validation, CAPA, and audit readiness. Candidates with general Quality, Validation, Manufacturing Quality, or Regulatory experience but limited direct medical device labeling experience are not considered a strong fit.
Work Arrangement
• Remote working.
