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Merz Therapeutics

Senior Manager Quality Engineering-Labeling

franksville, WI

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Job description

Job Title

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.

Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics.

Minimum 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

Preferred Qualifications:

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

Technical & Functional Skills:

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.

Benefits:

Comprehensive Medical, Dental, and Vision plans

20 days of Paid Time Off

15 paid holidays

Paid Sick Leave

Paid Parental Leave

401(k)

Employee bonuses

And more!

Your benefits and PTO start the date you're hired with no waiting period!

Work Authorization & Visa Sponsorship:

Applicants must be authorized to work in the United States without the need for employment‑based visa sponsorship now or in the future. Merz will not sponsor applicants for U.S. work visa status for this opportunity. No sponsorship is available for any employment‑based visas, including but not limited to H‑1B, L‑1, TN, O‑1, E‑3, H‑1B1, F‑1, J‑1, OPT, CPT, or any other employment‑based visa category.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

Worksite address

franksville, WI, 53126, US

Who can apply

Review the original listing for work authorization, qualifications and employer requirements.

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