Dir of Global Quality Systems

Company: Merz North America, Inc.
Location: Racine
Posted on: May 28, 2023

Job Description:

• Owner of eQMS Software System(s) 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 (SAP, MES, eQMS, etc.)Evaluate and implement new technologies
  • 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.
  • Define global quality system processes & collaborate with the site Quality Heads to ensure execution on site level, supporting the site leaders as needed
  • Collaborate with Global Site Quality Leaders to establish and execute digital strategies for Global Quality and Compliance DataInspections and Audits
    • QMS Subject Matter Expert for regulatory inspections and audits.
    • Allocates human resources and selects, acquires, and deploys appropriate methodologies to fulfill near term goals and commitments while ensuring sustainable quality performance.
    • Motivates and leads their organization to achieve business objectives.Budget
      • Manage Departmental Budgets in accordance with approved targets, work cross functionally to effectively support GTO budget targets.Work from home eligibility: Management DiscretionThis job description is an overview intended to describe the general nature and level of work being performed by individuals assigned to this job. The descriptions above are not intended to be an exhaustive list of all responsibilities, duties and skills required of the job. All employees may have other duties assigned at any time. -This job description may be altered at any time during employment with functions added, deleted and/or altered as necessary.Education
        • Higher Education (e.g. Bachelor's Degree) required
        • Master's Degree preferredProfessional Experience
          • 10 years minimum in the medical products industry required
          • 7 years in a Quality function preferreKnowledge, skills and abilities (incl. languages)
            • Excellent written and oral communication skills with attention to detail required
            • Demonstrated strong organizational skills including ability to prioritize tasks and adhere to agreed timelines required
            • Ability to host, facilitate and execute audits with internal and external audiences required
            • Highly computer literate (Word, Excel PowerPoint), including formatting and getting documents submission-ready required
            • Fluent in English (required), Additional Language Proficiencies are an assetKnowledge or methods
              • Proficient in eQMS design and implementation, ability to collaborate closely with internal and external IT/OT partners
              • Thorough understanding and knowledge of applicable regulations (ISO 13485, ISO 14971 and 21CFR Part 820 FDA regulations, MDSAP, MDD/MDR, and Canadian Medical Device Regulations (CMDR), etc.) - required
              • ASQ CQA, CQE, CQMOE - preferredPersonal skills
                • Ability to work effectively in a global, matrix environment required
                • Ability to work independently as well as direct and control the efforts of Direct Reports required
                • Strong interpersonal skills and ability to collaborate effectively with various technical area experts required
                • Comprehensive Medical, Dental, and Vision plans
                • 20 days of Paid Time Off
                • 15 paid holidays
                • 401(k)
                • 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!Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Keywords: Merz North America, Inc., Racine , Dir of Global Quality Systems, Other , Racine, Wisconsin