Senior Manager Quality Engineering-Labeling
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Do NOT repeat the job title as a heading (the page already shows it) and do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short
or drop it. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. IMPORTANT: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Prefer a few substantive sections over many thin ones. We need to decide which sections to include based on content. The posting includes: - About Us (company description) - A Brief Overview (role description) - What You Will Do (responsibilities) - Minimum Requirements (requirements) - Preferred Qualifications (qualifications) - Technical & Functional Skills (skills) - Benefits (benefits) - Work Authorization & Visa Sponsorship (maybe not a standard heading; but we could treat as a note, maybe not needed as a section; but it's substantive info about work auth. Could be included as a
under a generic "Additional Information" but not required. The instruction says only include sections when posting has real specific content for it. Work Authorization is specific content; but we don't have a standard heading for it. Could we create a custom heading? The instruction says use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It gives examples but not exclusive list. Probably we can use other headings if needed, but better to stick to those categories. Work Authorization could be folded into a short
under Benefits or maybe under a generic "Additional Info". However, we need to preserve all substantive info. Could include a
after Benefits. We must not include duplicated lines. Need to deduplicate repetitive sentences. Let's extract content. About Us: "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." A Brief Overview: "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." What You Will Do: list of responsibilities. Many sentences repeated. Need to consolidate into bullet list. Let's parse 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. We can combine similar points. Minimum Requirements: list: - 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. - Then a list of skills: 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 (actually separate section) but we have that as separate. 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. We need to output HTML fragment with sections. We need to decide headings: About Us could be "About the company" but instruction examples: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. They didn't list About Us. However we could treat "About Us" as a section heading maybe "About the company". But they said use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). The examples are not exhaustive but likely they expect those headings. However we have an "About Us" paragraph that is substantive. Could we put it under a heading like "About the company"? Might be okay. But to be safe, we could include a heading "About the company" as . The instruction didn't forbid other headings; just gave examples. So we can.
Alternatively we could merge About Us into a
without heading? But they said include a section ONLY when posting has real specific content for it — never emit a heading followed by filler/placeholder text. If we don't give a heading, it's not a section. But we need to preserve the About Us content. Could we just put it as a
at top without heading? The instruction says use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't say every paragraph must be under a heading. But typical format: sections with headings. However we could output a
for About Us then headings for other sections. That might be acceptable. But they said "Use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." So they expect headings for sections. The About Us could be considered "About the role"? No, that's about the role. But we have a brief overview of the role. That could be "About the role". Actually "A Brief Overview" is about the role. So we could use heading "About the role" for that paragraph. Then the initial "About Us" could be considered company info; maybe we could omit? But we need to preserve all substantive information. Could we incorporate About Us into a
under "About the role"? Not ideal. Better to create a heading "About the company". I think it's fine. Now we need to avoid duplicate lines. We'll deduplicate. Let's craft sections:
About the company
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.
About the role
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.
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 through effective oversight, review, audit support, and continuous process improvement
- Develop and implement quality improvement initiatives for labeling processes through process optimization, standardization, performance monitoring, and cross-functional collaboration to improve compliance, operational effectiveness, and inspection readiness