Quality Specialist

Job Summary:The Quality Specialist will obtain and maintain knowledge of current US and international regulations, guidance documents, and standards applicable to the Quality Management System. Further the Quality Specialist will ensure all current aspects of CurveBeam’s quality management system are being adhered to, utilized, and updated as required.Essential Duties and Responsibilities:Knowledgeable on all applicable state, national, and international regulations and standards.Meeting Regulatory Requirements ISO13485, the EU (MDR), FDA and other MDSAP countries.Overseeing company processes for all aspects of the Quality Management SystemDocumentation Control - Internal, Eternal and RecordsAudits - Internal and External Audits - Performs internal quality audits and effectiveness reviews (FDA’s QSR, ISO 13485, MDD/MDR, MDSAP).Suppliers - Conducts supplier evaluations and audits as applicable.Calibration - Ensure that equipment is calibrated and maintained in accordance with requirements, and that these activities are properly documented.Customer Complaints - Root cause analysis - CAPA determinationCorrective and Preventative actions - Ensue CAPA’s initiated, as appropriate, and completed.Non-Conforming Products - Review non-conforming components/products to ensure proper disposition.Design controls - Monitoring and assuring Design team is working within quality requirements.Employee Training programVerification and Validation - Process Validation - (Ensuring all processes are effective and appropriate) - QMS software validationAny other QMS process required to meet applicable standards and regulations.Performs other duties and tasks as assigned by the Director of Quality and Regulatory AffairsEducation Requirements: BS in an engineering, science, regulatory, or related discipline.Experience:Experience in preparing Quality Management Systems for Medical devices.Experience in an FDA regulated Class II electrical medical device manufacturing environment preferred.Computer Skills:Basic computer skills (operating system, file structure, network, etc.)Basic use of Microsoft products (Word, Excel, Outlook etc.)Other Desirable Experiences:Experience with leading the efforts for PMA and 510K filingsExperience with US Environment (EPA), Health and Safety (OSHA), Health Insurance Portability Accountability Act (HIPAA), General Data Protection Regulation (GDPR) regulationsExperience as Management RepresentativeStrong Interpersonal and Communicative SkillsStrong Problem-Solving SkillsTechnically InclinedKnowledge of X-Rays and human physiology a plusSelf-motivated, self-organized, and able to work with minimum supervision.Job Type: Full-timeBenefits:401(k)Flexible spending accountHealth insurancePaid time offSchedule:8 hour shiftEducation:Bachelor's (Preferred)Experience:Quality management: 1 year (Preferred)Process management: 1 year (Preferred)