Hill-Rom Software Quality Manager (QMR), QMS - Product Release, Post Market Surveillance, CAPAs (virtual/ remote from any eastern or central time US location) in Home Office/Virtual, New York
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.
One of Hillrom’s values is fun. That shows up in many ways throughout the year. You can enjoy summer hours in June, July and August with paid Friday afternoons off! Or put your passion in volunteering during the month October when we offer one half day of paid time off through Hillrom For Humanity. These are just a few examples of what makes Hillrom special.
Employee Resource Groups (ERG) are essential components of Hillrom’s commitment to drive inclusion to unify who we are and our purpose. They allow us to capitalize on the resources of Hillrom employees and support Hillrom’s commitment to Diversity, Equity, Inclusion, & Belonging. Our 7 ERGs foster an environment of belonging where all our voices matter. We hope we have you thinking about Hillrom.
True innovation is driven by the convergence of many opinions, skill sets, and life experience which is why Diversity, Equity, Inclusion and Belonging isn’t just good for society it’s good business. Hillrom is focused on building a workforce that represents our customers and our world while ensuring that all associates feels like they truly belong. We continue to evaluate progress in several areas of hiring, retaining talent from underrepresented groups which include ethnic minorities, Women, Veterans, Individuals with Disabilities and the LGBTQIA. Our commitment to Diversity, Inclusion and Belonging is part of our fabric.
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 digital health solutions
across our business units. Delivering the right information to the right people at the right time helps hospital staff care for
patients more safely, efficiently and effectively.
Hillrom’s Care Communications (located in Cary, NC) is a product portfolio comprised of communications apps and solutions including, mobile clinical communications solutions ( Voalte , located in Sarasota, FL), medical device integration (Excel, located in Jupiter, FL), alarm and alert management, waveform visualization and solutions for natural language processing. Together these solutions are focused on a vision of unifying the software platform to drive workflow efficiency, improve patient outcomes and strengthen patient engagement.
The Quality Manager is the Quality Management Representative (QMR) for the Sarasota, Florida facility. The Manager will have QA responsibility and oversight of site level (Sarasota, FL) software development and commercialization activities. S/he will also have shared service responsibilities across Care Communications to ensure organizational compliance to governing regulations for Software as a Medical Device (SaMD) to avoid regulatory action and assure a high level of product quality.
The Quality Manager is an individual contributor (no direct reports) who reports directly to the Director, Software QA, Care Communications. The Manager is expected to hire and build a team in the future.
The role is located at our Sarasota, FL facility. Alternatively, we welcome virtual/remote from any eastern or central time US location.
BASIC FUNCTION AND PRINCIPAL RESPONSIBILITIES:
QMR Responsible for Leadership of the Quality System, including Product Commercial Release, Post Market Surveillance and Corrective and Preventive Actions of the Sarasota site and supported products
Serves as a shared service member to Care Communications (sector level) for management reporting, QMS, audit readiness, site certification, and financial management
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 business operations
Ensure the post-market compliance of cybersecurity as a member of a threat sharing organization.
Provide guidance to the organization on regulatory implications of Artificial Intelligence and Deep Learning type algorithms.
Stay current with proposed regulations in the Medical Device Integration space, including process changes related to FDA pre-cert program.
Strive to influence the organization toward a higher quality and regulatory maturity level
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 QA oversight for new product development activities, including quality assessments, risk assessments, etc.
Supports submissions to governing regulatory agencies
Oversees field corrections and removals for Excel Medical products
Manages supplier quality activities, i.e. supplier evaluations, audits, and corrective actions
Reviews and approves clinical research and field validation activities for Excel Medical products
Coordinates quality operations for Excel Medical product inventory
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 review of V&V testing for critical projects
Provide guidance to individuals and teams for validation assessment and validation planning.
EDUCATION AND EXPERIENCE:
BS in engineering or other technical disciplines, software related degree preferred.
ASQ certification ideal.
Minimum 5 years of experience as QMR in software quality working in the QMS capacity with experience with Product
Commercial Release, Post Market Surveillance and Corrective and Preventive Actions.
Demonstrated ability to lead a team in the future.
Strong written and verbal communications skills.
Self starter, action/results oriented, impact and influence.
Primary Location: United States-Florida-Sarasota
Other Locations: United States-Illinois, United States-New York - Home Office/Virtual, United States-New Jersey - Home Office/Virtual, United States-Massachusetts-Acton, United States-Indiana - Home Office/Virtual, United States-Wisconsin - Home Office/Virtual, United States-Virginia - Home Office/Virtual, United States-Texas - Home Office/Virtual, United States-Tennessee - Home Office/Virtual, United States-Illinois-Chicago - Home Office/Virtual, United States-Florida-Naples - Home Office/Virtual, United States-New Jersey-Flanders - Home Office/Virtual, United States-North Carolina - Home Office/Virtual, United States-New Jersey, United States-Minnesota - Home Office/Virtual, United States-Maryland - Home Office/Virtual, United States-Illinois-Chicago, IL, United States-Texas-Austin, United States-Massachusetts-Boston, United States-Georgia - Home Office/Virtual, United States-Massachusetts - Home Office/Virtual, United States-North Carolina-Cary
Travel Yes, 10 % of the Time
Posting Entity Hillrom
Req ID: 21122653