Remote working
Job Title: Senior Labeling Quality Engineer / Labeling Quality SME
Experience: 10+ Years
Industry: Medical Devices
Focus: Medical Device Labeling, UDI, IFU, Artwork, Regulatory Compliance & Quality Systems
Position Overview
Integer is seeking a highly experienced Senior Labeling Quality Engineer / Labeling Quality SME with 10+ years of relevant experience in the medical device industry to provide senior-level quality and compliance oversight for medical device labeling activities.
The successful candidate will be responsible for ensuring that product labels, Unique Device Identification (UDI) codes, Instructions for Use (IFUs), packaging inserts, artwork, symbols, warnings, and associated labeling documentation comply with applicable global regulatory requirements and quality standards.
The ideal candidate must bring extensive hands-on medical device labeling experience with strong knowledge of FDA 21 CFR Part 801, EU MDR, ISO 13485, ISO 14971, UDI requirements, artwork/change control, labeling and printing process validation, CAPA, non-conformance investigations, and regulatory audit support.
This is a senior hands-on role requiring the ability to independently manage complex labeling quality activities, provide SME-level guidance, and collaborate with Quality, Regulatory Affairs, R&D, Human Factors, Manufacturing, Packaging Engineering, and other cross-functional teams.
Key Responsibilities
Regulatory & Standards Compliance
Serve as a senior Quality 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 and precautions
Storage and handling information
Other market-specific regulatory information
Ensure labeling information is accurately presented in both human-readable and machine-readable formats.
Assess regulatory and quality impact of proposed labeling changes.
UDI & Labeling Compliance
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.
Artwork & Label Lifecycle Management
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.
Risk Management & Usability Integration
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 are aligned 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.
Labeling & Printing Process Validation
Provide Quality oversight and support for validation of labeling, marking, and printing processes.
Support validation activities involving technologies such as:
Laser marking
Thermal transfer printing
Flexographic printing
Barcode printing and verification
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.
CAPA & Non-Conformance Investigations
Lead complex investigations involving:
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.
Quality Systems & Change Control
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
Validation activities
Maintain appropriate traceability and objective evidence throughout the labeling lifecycle.
Drive continuous improvement initiatives to strengthen labeling quality and compliance processes.
Audit & Inspection Readiness
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
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.
Required Qualifications & Experience
10+ years of overall relevant experience, with significant hands-on experience in Quality Engineering and medical device labeling.
7+ years of extensive experience working within the medical device industry is mandatory.
5+ years of strong hands-on experience with medical device labels, UDI, IFUs, packaging inserts, and artwork.
3 to 5 years of strong knowledge of FDA 21 CFR Part 801 and associated medical device labeling requirements.
3 to 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 with 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.
