Senior Labeling Quality Engineer / SME - Medical Devices

Company Overview:

Req ID: 396875

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NTT DATA's Client is currently seeking a Senior Labeling Quality Engineer / SME - Medical Devices to join their team in Pittsburgh, Pennsylvania (US-PA), United States (US). REMOTE

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:

Labeling errors

Mislabeling events or escapes

Incorrect artwork

UDI/barcode failures

Printing defects

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.

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.

Senior SME & Cross-Functional Leadership

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 & 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.

Critical Screening Criteria

Candidates should have strong, demonstrable hands-on experience across the following areas:

10+ years of relevant Quality/Labeling experience

Direct medical device industry experience Mandatory

Medical device labeling quality experience Mandatory

Product labels, UDI, IFUs, packaging inserts, and artwork

UDI-DI / UDI-PI and barcode compliance

FDA 21 CFR Part 801

EU MDR

ISO 13485

ISO 14971 and labeling risk integration

Artwork lifecycle, document control, and change control

Labeling/printing process validation

CAPA, non-conformance, and root-cause investigations

FDA / Notified Body / ISO 13485 audit support

Candidate Profile We Are Looking For

This is not a general Quality Engineer or Regulatory Affairs role. We are specifically looking for a very 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/label validation, CAPA, and audit readiness.

Candidates with strong general Quality, Validation, Manufacturing Quality, or Regulatory experience but limited direct medical device labeling experience should not be considered a strong fit.

About NTT DATA:

NTT DATA is a $30 billion trusted global innovator of business and technology services. We serve 75% of the Fortune Global 100 and are committed to helping clients innovate, optimize and transform for long term success. As a Global Top Employer, we have diverse experts in more than 50 countries and a robust partner ecosystem of established and start-up companies. Our services include business and technology consulting, data and artificial intelligence, industry solutions, as well as the development, implementation and management of applications, infrastructure and connectivity. We are one of the leading providers of digital and AI infrastructure in the world. NTT DATA is a part of NTT Group, which invests over $3.6 billion each year in R&D to help organizations and society move confidently and sustainably into the digital future. Visit us at us.nttdata.com

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