Hill-Rom Director Software Quality Assurance, Care Communications (digital health, healthcare IT HCIT, SaMD) in Home Office/Virtual, Massachusetts
Hillrom is a $2.9B global medical technology company with more than 10,000 employees worldwide. Every day, around the world, we enhance outcomes for patients and their caregivers. Our vision is all about Advancing Connecting Care from the doctor’s office, to the hospital, or the comfort of home. We focus on solutions that improve clinical and economic outcomes in five core areas: accelerating patient recovery, simplifying clinical communication and collaboration, enabling earlier diagnosis and treatment, optimizing surgical efficiency and safety, and shifting care closer to home.
Five values are the foundation of our corporate culture guiding us to enhance outcomes for patients and caregivers. Our values are Respect, Responsiveness, Results, Integrity and Fun; and are grounded in our six commitments: Patients and Caregivers are our Passion; Quality Matters in All We Do; Financial Discipline Drives Value; Innovation Fuels Our Growth; Continuous Innovation Creates Simplicity; and People Inspired to Win Together. These drivers guide Hillrom employees who play a critical role within the organization to drive and achieve our goals.
Hillrom's vision is a real-time, connected care environment that delivers actionable information to the right people at the right time. The company is in the process of interconnecting its portfolio of communication and patient flow solutions, along with its intelligent bed and therapy surface products, so they can share information among themselves and with other hospital products and systems. Delivering the right information to the right people at the right time helps hospital staff care for patients more safely, efficiently and effectively. To learn more watch this video .
The Director Software Quality Assurance, Care Communications has complete leadership responsibility for Quality/Regulatory strategy development and execution for the digital health (Care Communications) business for Hillrom. S/he is also the Quality Management Representative (QMR) and quality leader for the Cary, NC facility. Additionally, the Director will be responsible for Design Assurance and compliance of global technology related global software product development including software as a medical device (SaMD), as well as QA leadership throughout the Care Communications organization (Marketing, Sales/Service, Supplier, R&D, Manufacturing and Customer).
As the quality head for the Care Communications global business unit/area, the Director will direct activities related to quality control, quality assurance and regulatory compliance including strategies, staffing, scheduling, etc.; and develop the annual Care Communications quality strategy in collaboration with the VP of Design Assurance, Supplier Quality, PMO and Care Communications to ensure effective deployment and execution of the strategy.
The Director Software Quality Assurance, Care Communication, reports directly to the VP Design Assurance, Supplier Quality, PMO and Care Communications. The Director manages a team of 16.
ESSENTIAL DUTIES AND RESPONSIBILITIES: – Other duties may be assigned:
Develops corporate and/or organizational policies for the Care Communications global business unit and authorizes their implementation
Establishes strategy and direction for a business-critical function in alignment with the strategic plans established by executive leadership (both Care Communications and Quality)
Provides direction to senior managers in various groups, areas, and/or operations
Directs and controls the activities of one or more functional areas, divisions (i.e. design assurance, QMRs, complaint managers) for multiple sites within the Care Communications global business unit (i.e. Jupiter, Sarasota and Cary)
QMR Responsible for Leadership of the entire Quality System for Care Communications, including Product Commercial Release, Post Market Surveillance and Corrective and Preventive Actions
Serves as a member of the Care Communications Leadership Team as the representative for the QA/RA function
Provides partnership, insight and direction to cross-functional business leaders and stakeholders regarding Digital Health QMS policies, solutions, and initiatives
Ensure a high degree of inspection readiness for systems within scope of responsibility
Comprehensive quality leadership for the Care Communications global business unit throughout the entire product lifecycle (concept though end of life). Develops long term and annual quality functional strategy
In conjunction with the Design Assurance organization, develop global design assurance strategies for oversight of R&D activities to ensure new product launches are successful
In partnership with the global Supplier Quality organization, develop appropriate supplier quality practices for 3rd party direct materials suppliers and technology-based solutions (hosting, connectivity, software)
Creates an environment that fosters collaborative teamwork within and across functions
Well versed in product quality and compliance strategies for products classified as Software as a Medical Device (SaMD), Software in Medical Device (SiMD, Medical Device Data Systems (MDDS) and non-regulated health software
Effectively plans and organizes the work of teams and effectively utilizes resources to get things done
The role is located at our facility in Cary, NC (Raleigh/Durham/Research Triangle Park). Consideration may be given for remote/virtual work in the US, Canada or Latin America.
Bachelor’s degree is required; engineering, other technical disciplines, software related degree preferred.
Minimum 15 years of experience in Quality Assurance or Regulatory Affairs (5 of those in a leadership position) 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)
Technology solutions and processes, including connectivity, analytics (AI/ML), infrastructure services, hosted solutions
Quality processes including technology lifecycle management, Design Controls, NCE/CAPA, Complaints management
Good communicator, developing quality strategies/Quality Management System elements, managing resource demand (fast/frequent releases)
Primary Location: United States-North Carolina-Cary
Other Locations: United States-New York - Home Office/Virtual, United States-Illinois - Home Office/Virtual, United States-Michigan - Home Office/Virtual, Mexico-Distrito Federal-Miguel Hidalgo - Home Office/Virtual, United States-Indiana - Home Office/Virtual, United States-Missouri - Home Office/Virtual, United States-Wisconsin - Home Office/Virtual, United States-Tennessee - Home Office/Virtual, United States-North Carolina - Home Office/Virtual, Colombia, Canada, United States-Ohio - Home Office/Virtual, Mexico, United States-California - Home Office/Virtual, Argentina-Buenos Aires - Home Office/Virtual, United States, United States-New Jersey-Newark - Home Office/Virtual, United States-Pennsylvania - Home Office/Virtual, United States-Texas - Home Office/Virtual, United States-Illinois-Chicago - Home Office/Virtual, Chile, United States-Kansas - Home Office/Virtual, Colombia-Distrito Capital de Bogotá-Bogotá - Home Office/Virtual, United States-Minnesota - Home Office/Virtual, United States-Florida - Home Office/Virtual, United States-Georgia - Home Office/Virtual, United States-Massachusetts - Home Office/Virtual, Brazil-Brazil - Home Office
Travel Yes, 10 % of the Time
Posting Entity Hillrom
Req ID: 21122766