Software Quality Manager SaMD QMR

Company: Hill-Rom
Location: Jupiter
Posted on: October 9, 2020

Job Description:

This role is the Quality Management Representative (QMR) for the Care Communications entity based in Jupiter, FL. This role will have QA responsibility and oversight of global software development and commercialization activities. This role will 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. ESSENTIAL DUTIES AND RESPONSIBILITIES: - Other duties may be assigned: - QMR Responsible for Leadership of the Quality System, including Product Commercial Release, Post Market Surveillance and Corrective and Preventive Actions - Serves as a member of the Excel Medical Leadership Team as the representative for the QA 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 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. #INDHR - BS in engineering or other technical disciplines, software related degree preferred. - Minimum 5 years of experience in Quality Assurance or Regulatory Affairs, software as a medical device experience required. - Minimum of 5 years leadership experience (People development, written and verbal communications skills, action/results oriented, impact and influence). Hillrom is a $2.9B leading worldwide manufacturer and provider of medical technologies and related services for the health care industry, including patient support systems, safe mobility and handling solutions, non-invasive therapeutic products for a variety of acute and chronic medical conditions, medical equipment rentals, surgical products and information technology solutions. Hillrom's comprehensive product and service offerings are used by health care providers across the health care continuum and around the world in hospitals, extended care facilities and home care settings to enhance the safety and quality of patient care. Hillrom is an equal employment employer F/M/Disability/Vet/Sexual Orientation/Gender Identity Job Quality Primary Location United States-Florida-Jupiter Schedule Full-time Travel Yes, 10 % of the Time Posting Entity Hillrom

Keywords: Hill-Rom, Jupiter , Software Quality Manager SaMD QMR, IT / Software / Systems , Jupiter, Florida