Coloplast has an exciting opportunity for a Global Director of Quality to join our Interventional Urology team.

You will be responsible for leading quality systems, quality engineering, quality assurance, supplier quality, design assurance and documentation control functions to assure compliance with applicable regulations and corporate requirements. In this role, you will lead a global team in both the US and France.

Major Areas of Accountability

• Develop and set strategic direction for global quality organization including quality systems, quality assurance, supplier quality, design assurance and documentation control.
• Lead and manage global quality team by monitoring and maintaining department goals and individual objectives.
• Drive and lead the execution of the global quality management system across the IU organization and ensure compliance with global regulations.
• Lead project teams that support the development of quality deliverables per the project plans and active monitoring of conformance to the design assurance requirements to ensure they meet the intended use and user needs, while assuring quality and reliability.
• Lead team that manages supplier quality relationships and ensure quality standards are being met.
• Lead the global internal audit program, monitoring compliance to schedules for resulting action items.
• Lead CAPA and complaint handling systems, ensuring timely reporting, adequate root cause investigations and compliance to schedule on resulting action items.
• Direct the training program for assuring understanding of quality requirements to support compliance with procedures/instructions and applicable regulations, as well as communicating quality management system effectiveness to the organization.
• Lead documentation control to ensure compliance with quality standards and regulations.
• Regularly review and maintain corporate and local procedures/instructions to assure ongoing compliance as needed.
• Lead inspections by external audits by FDA, ISO notified body quality audits, customers or other appropriate agencies.
• Manage product reviews, product launch surveillance, and management reviews while contributing to post-market surveillance and adverse event reporting.
• Review quality and process performance data against acceptance criteria and provides strategic direction to improve performance and compliance.
• Perform complaint processing and analysis as needed.
• Lead global quality function to ensure stakeholder management and engagement with cross-functional global teams.
• Identify opportunities to continuously improve quality efficiency, costs and time factors consistent with business objectives.
• Manage department financial budget to include capital, expense, resources, etc.
• Manage performance management process for direct reports.
• Conforms with Coloplast Q/EHS Policy
• (http://www.coloplast.com/About/responsibility/Documents/QEHS%20policy.pdf)
• Other duties, as assigned.

Basic Qualifications

• Bachelor's degree in an applied technical discipline, engineering preferred
• Minimum of 15 years' quality experience in medical device and pharmaceuticals.
• 8+ years of leadership experience is preferred.
• Demonstrated knowledge and application of FDA and ISO quality system requirements
• Ability to travel up to 20%
• Excellent written and oral communication skills
• Experience with quality systems
• Experience in quality engineering principles including design assurance, root cause analysis, sample plans, validation, stability testing, quality plans, change control, and others is required
• Experience leading FDA inspections and ISO registrar audits is required