Quality Director In Medical Devices Jobs (NOW HIRING)

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Full Time Not Reported USPC Erlanger, Erlanger, KY, US

30+ days ago Requisition ID: 2196

As Global Quality Director for the Entertainment Business, you will set and lead the global quality strategy across our playing cards portfolio, manufacturing footprint, and supply chain. You will ensure that products consistently meet customer expectations, regulatory requirements, and internal standards for quality, product safety, and product security. Acting as a strategic partner to Operations, Sourcing, Product Development, Commercial, and senior leadership teams, you will build a prevention-led quality culture focused on continuous improvement, customer trust, and operational excellence.

Key responsibilities

• Quality
  • Own and continuously improve the Quality Management System for the Entertainment Business, ensuring compliance with relevant international standards such as ISO 9001, customer-specific requirements, regulatory expectations, and internal policies.
  • Ensure the quality management processes deliver the required outputs, measure and report their performance, identify opportunities for improvement, and implement changes to strengthen effectiveness and customer satisfaction.
  • Define global quality standards for new or changed products to prevent potential quality defects and support reliable product launches and changes.
  • Define, localize, initiate, and coordinate improvement actions that enhance product quality, reduce quality‑related cost, and improve the total cost of ownership for quality issues.
  • Lead functional teams in the use of FMEA, quality control plans, 8D, risk assessments, CAPA, and lessons learned to drive preventive quality and continuous improvement.
  • Train and support personnel on procedures, work instructions, quality tools, and the continuous stimulation of a quality mindset and Q‑philosophy across the organization.
• Product Safety
  • Continuously improve the process that ensures products comply with applicable product safety regulations and market requirements, including EN 71, the Toy Safety Directive 2009/48/EC, REACH, CPSIA, and related testing and documentation expectations.
  • Ensure robust risk assessments, safety assessments, testing, technical documentation, release controls, and follow‑up actions for products within the Entertainment portfolio.
  • Provide training and guidance on product safety requirements to the organization to strengthen awareness, compliance, and ownership across relevant functions.
• Product Security
  • Implement, maintain, and adjust the Cartamundi management system within the Entertainment Business to safeguard product security, product integrity, customer confidence, and brand reputation.
  • Strengthen product security processes, controls, governance, and escalation mechanisms to identify risks and ensure consistent execution across sites, regions, suppliers, and functions.

You stay close to customers, consumers, and market expectations, using their feedback to improve quality performance, product reliability, and overall customer satisfaction.

You act as the senior point of reference for quality‑related communication with customers, suppliers, certification bodies, and internal stakeholders, ensuring clear decisions, strong alignment, and rapid resolution of issues.

• Define and deploy the standards, tools, governance, and reporting required to maintain an effective, documented, and auditable quality management system.
• Initiate and lead corrective, preventive, containment, and escalation actions required to protect product quality, compliance, customer interests, and brand reputation.
• Make or escape decisions related to product release, quality hold, containment, rework, destruction, or market recall in close alignment with senior quality and business leadership.

What you bring

• Master’s degree in Engineering, Quality, Industrial Sciences, or a related technical field.
• Extensive senior leadership experience in quality within manufacturing, consumer goods, print, packaging, toys, games, or a comparable international product environment.
• Strong expertise in quality management systems, continuous improvement, root cause analysis, audit management, supplier quality, and preventive quality methodologies such as FMEA, control plans, 8D, CAPA, and risk assessment.
• Solid understanding of product safety and regulatory requirements relevant to international consumer products, including EU and US market expectations such as the EU Toy Safety Directive 2009/48/EC, EN 71, REACH, CPSIA, and related testing and documentation requirements.
• Proven ability to lead and develop international teams, influence senior stakeholders, and translate complex quality topics into practical business decisions and actions.
• Strong communication and presentation skills, with the confidence to engage effectively with customers, suppliers, auditors, certification bodies, and internal teams across regions.
• A hands‑on, data‑driven, and strategic mindset, with a passion for continuous improvement and operational excellence.
• Willingness to travel internationally as required.
• Fluent in English; additional languages are an asset.