Manages the Quality and Compliance departments (Quality Systems, Supplier Quality, Software Quality Assurance, Q&C New product Development)
• Oversees directly and indirectly organization of Quality and Compliance professionals, such as engineers and scientists that focus on quality aspects of development, lifecycle, supply chain, production and support. Includes partnership in new product development and leadership in supplier qualification, product release, field actions and complaint resolution activities.
• Leads effective establishment of organizations that support business process and compliance, quality risk management, design assurance, internal audits, corrective and preventive action, records management and document control, complaint management and medical device reporting and management of quality data across disciplines
• Partners with business and functional leaders to drive risk mitigation, proactive action, and continuous improvement.
• Interfaces with the designated Official Correspondent, Notified Bodies and Regulatory Authorities in matters of communications, actions and inspections and audits.
• Acts as Management Representative and the Person Responsible for Regulatory Compliance (PRRC)for HTC site.
• A minimum of 10 years of regulated products experience, with a minimum of 5 years in quality management or related functions
• Experience in new product development including software & hardware designs
• Ability to interpret standards and regulations and apply as an input to all company activities and management decisions
• Balanced technical understanding of products and processes combined with superior business and compliance acumen
• Ability to recognize, build support for change and engage in constructive conflict
• High tolerance for ambiguity in a complex environment
• Ability to make the complex clear and easily understood by others
• Strong collaboration and influence management skills to partner effectively.