Director of Global Quality Systems

Merz North America • Caledonia, WI

90d

About The Position

Accountable for the development, execution and delivery of global quality systems strategies for Merz Aesthetics. Partner with Quality Site Heads, Global Quality Functions, R&D, Supply Chain, Operations & Marketing to assure Global Quality Objectives are identified and fulfilled. Drive continuous improvement in the overall quality systems infrastructure for Merz Aesthetics sites. 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.

Requirements

• Bachelor's Degree
• 10+ years Minimum in the medical products industry
• Ability to host, facilitate and execute audits with internal and external audiences.
• Highly computer literate (Word, Excel PowerPoint), including formatting and getting documents submission-ready.
• Fluent in English, Additional Language Proficiencies are an asset.
• 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.).
• Lean / Six Sigma Green Belt.
• ASQ CQA, CQE, CQMOE.
• Ability to work effectively in a global, matrix environment.
• Ability to work independently as well as direct and control the efforts of Direct Reports.
• Strong interpersonal skills and ability to collaborate effectively with various technical area experts.

Nice To Haves

• Master's Degree
• 7+ years in a Quality function

Responsibilities

• 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 per Quality System Standards, Quality System Regulations, and other company procedures.
• 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.
• Collaborate with Global Site Quality Leaders to establish and execute digital strategies for Global Quality and Compliance Data.
• QMS Subject Matter Expert for regulatory inspections and audits.
• Manage Departmental Budgets in accordance with approved targets.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Wholesale Trade Agents and Brokers
• Education Level: Bachelor's degree