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Senior Manager/Associate Director of Global Quality Systems

Job Overview

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Employment Type

Full-time
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Compensation

Type:
Salary
Rate:
Range $86,700.00 - $133,200.00
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Work Schedule

Standard Hours
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Benefits

comprehensive medical
Dental
vision plans
20 days of paid time off
15 paid holidays
Paid sick leave
Paid parental leave
401(k)
employee bonuses

Job Description

Merz is a distinguished family-owned specialty healthcare company established in 1908, boasting a rich heritage and a solid reputation in the global aesthetics industry. As a leading force in aesthetic medicine, Merz offers an award-winning portfolio that includes injectables, devices, and skincare products designed to empower healthcare professionals worldwide. Their mission centers on fueling confidence by helping people look better, feel better, and live better. The values of Merz emphasize that one should not have to choose between living life fully and making a living; they encourage living the best life possible alongside professional success. Merz Aesthetics is committed to... Show More

Job Requirements

  • Bachelor's degree
  • 10+ years minimum in the medical products industry
  • Ability to work independently and direct and control the efforts of direct reports
  • Ability to work effectively in a global, matrix environment
  • Strong interpersonal skills
  • Proficient computer skills
  • Fluent in English

Job Qualifications

  • Master's degree
  • 7+ years in a quality function
  • Ability to host, facilitate and execute audits with internal and external audiences
  • Highly computer literate including Word, Excel, PowerPoint
  • Fluent in English, additional language proficiencies are an asset
  • Proficient in eQMS design and implementation
  • Thorough knowledge of ISO 13485, ISO 14971, 21CFR Part 820 FDA regulations, MDSAP, MDD/MDR, Canadian Medical Device Regulations
  • Lean/Six Sigma Green Belt
  • ASQ CQA, CQE, CQMOE
  • Ability to work effectively in a global, matrix environment
  • Strong interpersonal skills and ability to collaborate with various technical area experts

Job Duties

  • Global Quality System Infrastructure Owner of eQMS software systems and their design, installation, qualification and deployment to Merz Aesthetics global manufacturing sites and affiliates
  • Develop company-wide quality systems roadmap and define priorities in line with global stakeholder needs and requirements
  • Owner of quality master data strategy and execution into applicable systems including SAP, MES, and eQMS
  • Evaluate and implement new technologies per quality system standards, regulations, and company procedures
  • Identify new quality improvement initiatives and projects that enhance compliance, reduce defects, and improve operational efficiencies
  • Define global quality system processes and collaborate with site quality heads for execution and support
  • Serve as QMS subject matter expert for regulatory inspections and audits
  • Allocate human resources and deploy methodologies to fulfill goals while ensuring sustainable quality performance
  • Motivate and lead the organization to achieve business objectives
  • Manage departmental budgets and support cross-functional budget targets effectively

Job Qualifications

Experience

Expert Level (7+ years)

Job Location

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