NOTE- this can be 100% remote for right person Description: Primarily responsible for representing QA on cross-functional Software as a medical device (SaMD) and Digital Health Software product development teams and executing Quality System requirements to ensure products are developed, tested, and released in compliance with worldwide Medical Device Regulations. Responsible for authoring, reviewing, and approving project documentation associated with the SDLC and design control requirements to support Corporate, Division, FDA, and other regulatory requirements. In addition to these primary areas of focus, quality assurance will also be responsible for creating and maintaining QMS documents for the development of SaMD’s and Digital Health Software Products in compliance with global regulations.
Responsibilities:
Perform QA activities related to Software as a Medical Device (SaMD) and Digital Health Software Product Development
Ensure compliance with software lifecycle policies and procedures.
Perform design control and risk management activities according to Quality System
Partner with technical teams to ensure design control documentation (Risk Management, Traceability/Linkages) & design change control requirements are met.
Support the creation of regulatory submission documentation.
Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure.
Initiate assignments independently. Actively lead and participate on development and process improvement teams. Anticipate/resolve quality issues and take preventative actions.
Actively monitor effectiveness of processes and quality of project work, propose and execute quality/process improvements.
Write/review policies/processes/procedures and related documents for the development of SaMD’s and Digital Health products in compliance with global regulations.
Apply knowledge of global regulations, guidance's, and Corporate and Function standards.
Lead/assist in the preparation of and support regulatory agency and internal audits.
Qualifications:
Bachelor’s degree or equivalent is required; preferably in sciences, engineering or other technical/scientific area.
5+ years of industry experience in Quality Assurance, Development or healthcare related field. Experience in Medical devices, specifically development of Software Medical Devices is desired.
Strong understanding of regulations and standards affecting software medical devices such as IEC 62304, 21 CFR 820.30 and EU MDR.
Experience with creation and maintenance of QMS documents for development of medical devices.
Experience in coordination and planning of complex activities and ability to identify and resolve complex problems through effective use of technical and interpersonal skills.
Product development experience (e.g. approaches for definition of requirements and specification setting for verification and validation). Practical experience in design control and risk management.
Effective use of oral and written communication skills to clearly communicate the quality position, and the actions necessary to resolve issues.
Interpersonal, team, leadership, and negotiation skills to handle conflicting priorities.
Strong oral and written communication skills, excellent interpersonal and cross-cultural skills required.
Capable of clearly presenting and justifying quality requirements to management.
What are the top 3-5 skills requirements should this person have?
Software medical device experinece
Medical device regulation IEC 62304, 21 CFR 820.30 and EU MDR
Experience creating and maintaining qms (quality mgmt. system) documents
Experience in software quality assurance in regulated space
What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
Experience in Medical devices, specifically development of Software Medical Devices is desired
