Director of Quality Systems Management
PhysIQ is a transformational leader in applying highly sophisticated technology to solve some of the most pressing problems in healthcare. More specifically, we are forging the frontier of healthcare delivery at the intersection of mobile technology and artificial intelligence. Our team is comprised of veteran technologists and world-class data scientists and our solutions set the market standard for scalability and sophistication. Furthermore, we are implementers with a proven track record of transforming an audacious technological vision into mission-critical solutions for our customers.
- Our core values are simple and are defined by integrity, passion and relentless drive toward solving the impossible.
- We are a team in its purest definition. We all pull on the rope together, in the same direction, with the same intensity.
- Our customers and their patients depend on us to deliver technology that will forever change healthcare. We are literally keeping people out of the hospital. We are changing lives.
In our world, amazing things only happen when people make them happen. If you want to make things happen and do it with a world-class of team of visionaries and doers, we encourage you to apply.
PhysIQ is seeking a talented and experienced team member to assume leadership responsibility for our company-wide quality management system (QMS) to advance our established start-up organization in compliance with federal law. The Director of Quality Systems Management will advance the current maturity of, maintain the ongoing compliance with, and assess the effectiveness of physIQ’s quality management system in order to ensure the company meets or exceeds standards as established by the FDA and other regulatory authorities. In particular, the candidate is expected to bring direct industry experience in Software as a Medical Device (SaMD) quality systems to facilitate FDA regulatory filings and international technical dossiers toward commercialization.
- Advance the functionality and maturity of the current quality management system toward optimal
- Maintain the entire company quality system through company document control system
- Assess the effectiveness of the current company-wide quality management system; make recommendations for improvement and take appropriate action therewith
- Manage complaints and preside over the Complaints Committee Team Meetings. To follow up with customer and regulatory communique, including medical device reporting (MDR).
- Manage corrective and preventive action (CAPA) subsystem and assess CAPA effectiveness
- Maintain company establishment annual registration and device listings
- Manage UDI systems with GUDID and other medical device tracking systems
- Ensure SOPs are accurately documented, maintained, and updated and that assigned trainings are completed
- Contribute to / participate in all Management Review Meetings, as functional area expert
- Participate and facilitate all internal audits and external audits including regulatory inspections
- Contribute to risk analyses as part of candidate product design history files (DHF)
- Contribute to all regulatory submissions including Class I 510(k) exempt design history files, Class II 510(k) submissions, CE mark technical dossiers, among others
- Implement and manage quality agreements with vendors, as needed
- Participate in developing, tracking, and assessing quality plan objectives
- Participate in Human Factors / Usability Engineering planning and testing, where applicable
- Bachelor’s degree in related field; advanced degree preferred
- 5+ years in a Regulatory Quality Affairs role, particularly with Software as a Medical Device (SaMD) systems
- Must have working knowledge of the following:
- Software as a Medical Device (SaMD); Clinical Decision Support Software (CDS); 21 CFR Part 11 Electronic Records and Electronic Signatures; 21CFR820 Quality Systems Regulation; ISO13485:2016 Quality Management Systems — Requirements for Regulatory Purposes; ISO14971:2019 Medical Devices - Application of Risk Management to Medical Devices; Unique Device Identifier (UDI) Final Rule o Establishment Registration and Listing; Guidance for Industry (2005): Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices o Guidance for Industry (2017): Deciding When to Submit a 510(k) for a Software Change to an Existing Device o Health Information Portability and Accountability Act (HIPAA)
Nice to Have
- International Medical Device Regulation Forum (IMDRF)
- IEC62304:2006 Medical Device Software — Software Life Cycle Processes
- FDA Quality System Inspection Technique (QSIT)
- REGULATION (EU) 2017/745 (preferred)