About the Company:
Merz is a family-owned medical device and pharmaceutical company headquartered in Germany. Our Global Technical Operations based in WI manufactures, packages and ships several innovative products so that people all over the world can live better, feel better, and look better.
The Global Quality Systems Manager support the development, execution and delivery of global quality systems strategies for Merz Aesthetics. They partner with Quality Site Heads, Global Quality Functions, R&D, Supply Chain, Operations & Marketing to assure Global Objectives are identified and fulfilled.
They drive continuous improvement in the overall quality systems infrastructure for Merz Aesthetics sites. They provide support to other departmental activities as directed. They provide Subject Matter Expertise in evaluation and implementation of domestic and international regulatory GMP requirements.
Key Responsibilities:
Quality System Infrastructure
- Collaborate to ensure eQMS Software System(s) and their design, installation, qualification and deployment to Merz Aesthetics Global Manufacturing Sites and Affiliates fulfills global requirements and user needs.
- Support the development and execution of company-wide Quality Systems roadmap and define priorities in line with global stakeholder needs and requirements.
- Support creation of Quality Master Data Strategy and Execution into applicable systems (SAP, MES, eQMS, etc.)
Evaluate and implement new technology
- Evaluate and implement new technologies per Quality System Standards, Quality System Regulations, and other company procedures around which the Quality System is developed.
- Identifies new quality improvement initiatives / projects in accordance with cGMP expectations to improve compliance, quality levels (reducing defects), and improve operational efficiencies.
- Drive global data digitalization projects
Global alignment and Strategy
- Drive the implementation of company-wide eQMS tools and technologies in alignment with global strategy
- Collaborate to define global processes & support the site Quality teams to ensure execution on site level, supporting the site leaders as needed
- Facilitate the harmonization of quality system tools and ensure they are aligned across functions
- Collaborate with Global Site Quality Leaders to implement digital strategies for Global Quality and Compliance Data
Knowledge and Skills:
- Familiarity with of ISO13485 ISO14971, 21CFR 210,211, 820, European MDR and MDSAP. Required
- Experience in use and configuration of electronic Quality System Software. Required
- Solid experience in problem solving and statistics. Required
- Demonstrated strong organizational skills including ability to prioritize tasks and adhere to agreed timelines. Preferred
- Fluent in English; Additional Language proficiencies are an asset. Required
- Ability to work effectively in a global, matrix environment. Required
- Strong interpersonal skills and ability to collaborate effectively with various technical area experts. Required
Education:
- Higher education scientific or equivalent. Required
- Master’s Degree in Science. Preferred
Experience:
- Minimum 7 years of proven experience in the field of medical devices and/or pharmaceutical products. Required
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!
Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees!
Racine, Wisconsin
Full Time, Contractor