Senior Manager Quality Engineering-Labeling

Merz North America•Franksville, WI

About The Position

This role is responsible for labeling quality and compliance activities to ensure product labeling meets regulatory requirements, industry standards, and company policies. Oversees Product Labeling and New Markets functions while supporting Risk Management and Change Control processes. Drives continuous improvement, operational excellence, and inspection readiness across multiple teams and geographies. Provides strategic leadership for labeling development, review, approval, and lifecycle management, ensuring labeling accuracy, compliance, and product quality. Partners cross-functionally to support product launches, market expansions, quality initiatives, product changes, and risk assessments while developing talent, resolving complex compliance issues, and strengthening quality systems to support business objectives and patient safety.

Requirements

Bachelor of Science (B.S.) Life Sciences, Engineering, Regulatory Affairs, or related technical discipline
5+ years Progressive experience in Quality, Quality Engineering, Regulatory Affairs, Labeling, or related functions within a regulated industry (medical device, pharmaceutical, biologic, or combination products).
3-5 years Experience leading cross-functional initiatives and influencing business decisions across multiple functions and organizational levels.
First Leadership experience managing professional staff, developing talent, and leading department or functional objectives.
Quality Assurance
Process Improvement
Compliance Management
Cross-Functional Collaboration
Risk Assessment
Project Management
Technical Writing
Data Analysis
Problem Solving
Critical Thinking

Nice To Haves

Master's Degree Physical science, engineering, business, or relevant field
Certification(s) – ASQ Quality Assurance Certified Quality Engineer certification
Lean Six Sigma Certifications (Yellow Belt, Green Belt, Black Belt)
Six Sigma certification (green belt or higher)
Certification(s) – ASQ Quality Assurance Certified Quality Manager
Expert knowledge of quality systems, quality techniques, regulatory requirements, and quality engineering principles.
Advanced knowledge of labeling regulations, standards, and global compliance requirements.
Thorough understanding of Quality System requirements including documentation, records management, change control, CAPA, and risk management.
Ability to lead complex investigations, root cause analyses, and continuous improvement initiatives.
Ability to develop and implement quality strategies, policies, and engineering standards.
Ability to provide leadership, coaching, and development to quality engineering staff.
Ability to collaborate and influence effectively across global cross-functional teams and senior leadership.
Ability to make sound business decisions and balance quality, compliance, and operational objectives.
Experience leading regulatory inspections, audits, and inspection readiness activities.
ASQ Certification (CQE, CMQ/OE) and/or Lean Six Sigma Certification.

Responsibilities

Manage and oversee labeling quality assurance processes and systems
Oversee labeling quality processes and systems to ensure labeling accuracy, compliance, and consistency.
Support labeling review, approval, document control, risk management, and change control activities while driving continuous improvement and regulatory compliance.
Ensure compliance with industry regulations and standards for labeling
Ensure labeling activities comply with applicable regulatory requirements, industry standards, and company policies through effective oversight, review, audit support, and continuous process improvement.
Develop and implement quality improvement initiatives for labeling procedures
Drive strategic quality improvement initiatives for labeling processes through process optimization, standardization, performance monitoring, and cross-functional collaboration to improve compliance, operational effectiveness, and inspection readiness.
Monitor and evaluate labeling processes to ensure accuracy and reliability
Provide oversight of labeling process performance through monitoring, trend analysis, and quality metrics to ensure labeling accuracy, reliability, compliance, and continuous improvement across the product lifecycle.
Collaborate with cross-functional teams to address labeling-related quality issues
Lead cross-functional efforts to address complex labeling quality and compliance issues, driving timely resolution, risk mitigation, and sustainable process improvements to support product quality and regulatory compliance.
Support Change Control and Risk Management Activities
Provide support and oversight for risk management and change control processes to ensure effective evaluation of changes, mitigation of risks, and compliance with quality system and regulatory requirements.