Overall responsibility for leading the corporate product quality systems, including the setting of quality goals, managing and improving all aspects of the quality system and product quality to ensure corporate compliance with US FDA or other applicable competent authority regulations, policies, and guidelines.
- Provide management and leadership to the Regulatory Affairs, Quality Assurance and Product Quality functions in the development and implementation of regulatory strategies and processes, including a quality system, to ensure that Xcision complies with all applicable federal, state and local regulations in the US (including FDA, NRC, etc.) governing the manufacturing, sale and service of radiation-emitting medical devices.
- Demonstrate a strong working knowledge of international quality and regulatory requirements that impact Xcision’s ability to operate in other selected markets (such as Health Canada, CE marking in Europe, ISO, IEC, etc.
- Act as Management Representative for Quality System Management Reviews
- Coach and mentor the Quality and Regulatory team to ensure appropriate levels of accountability for decision making and clearly communicate cross functionally within the organization
- Host/manage internal audits, third-party audits, manage audit responses and non-conformities
- Review/enter complaints and potentially reportable events, manage recalls and related reporting
- Develop controlled documents, QA tools, and procedures pertinent to QA activities and functions, as well as other procedures deemed necessary to ensure independent oversight of quality-related functions including design and development, production and purchasing activities
- RA/QA training-develop and review material, identify needs/gaps, conduct training
- Manage consultants and their contracts for assigned QA/RA projects
- Ensure that Standard Operating Procedures (SOPs) are developed, implemented and maintained to be in compliance with current regulations and applicable standards
- Manage compliance to requirements for clinical studies, regulatory submissions, regulatory correspondence, registrations, licenses, labelling.