This role has complete leadership responsibility for Quality/Regulatory strategy development and execution for the Care Communications business for Hillrom. This role is also the Quality Management Representative (QMR) for the Care Communications entity based in Cary North Carolina. In addition, this role will have responsibility and oversight for compliance of global software development activities. This role will ensure organizational compliance to governing regulations to avoid regulatory action and provide QA/RA leadership throughout the Care Communications organization (Marketing, Sales/Service, Supplier, R&D, Manufacturing and Customer).
ESSENTIAL DUTIES AND RESPONSIBILITIES: – Other duties may be assigned:
• QMR Responsible for Leadership of the entire Quality System for Care Communications, including Product Commercial Release, Post Market Surveillance and Corrective and Preventive Actions• Leadership and development opportunities for Quality/Regulatory associates• Serves as a member of the Care Communications Leadership Team as the representative for the QA/RA function• Serves as FDA Quality Management Representative facilitating company audits and Quality Management Reviews• Ensures appropriate controls (measured by key metrics) are defined, implemented and satisfactorily completed for all Care Communications business operations• Drives data analysis of quality performance to identify high priority issues relating to safety, complaints and systemic customer satisfaction• Provides training resources to ensure proper implementation and use of quality tools and procedures as required• Enables rapid and effective correction of quality/regulatory problems in a manner that prevents recurrence• Provides customer correspondence in response to quality issues, inquiries, or requests• Evaluates compliance risks and develops risk mitigation strategies for the business• Provides regulatory oversight for new product development activities, including regulatory assessments, risk assessments, etc.• Coordinates submissions to governing regulatory agencies• Oversees field corrections and removals for Care Communications products• Manages supplier quality activities, i.e. supplier evaluations, audits, and corrective actions• Reviews and approves clinical research and field validation activities for Care Communications products• Coordinates quality operations for Care Communications product inventory• Develops and manages QARA Care Communications budget• Provides guidance and oversight for Hillrom global software development activities to drive best in class processesCorporate Quality System Process Owner for Software is responsible for the following:• Owning the respective QMS architecture and processes• Continually improving the respective QMS elementSoftware QS Process Owner - The respective QS Process Owner for Software Development and Validation processes shall:• Chair Software Design Assurance Council.• Work with the respective Hillrom experts (R&D, engineering, IT, QA/RA) to oversee and maintain the software development and validation procedure(s) associated with a product’s life cycle.• Ensure processes are compliant, efficient, and leverages best practices• Provide high level review of V&V testing for critical projects• Provide guidance to individuals and teams for validation assessment and validation planning• Identify the specific roles and responsibilities for non-product software validation activities.• Establish appropriate deliverable approvals.• Provide guidance, consultation, and approval (as applicable), for regulatory impacted software products.• Develop and Lead Software Development and Validation Council to support learning and implementation.
• BS in engineering or other technical disciplines, software related degree preferred.• Minimum 10 years of experience in Quality Assurance or Regulatory Affairs, software as a medical device experience preferred.• Successful record of leading people and complex projects.• Minimum of 5 years leadership experience (People development, written and verbal communications skills, action/results oriented, impact and influence).