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We have an exciting opportunity in our Irvine office to assist Department management in the Healthcare Solutions Division with quality programs and system activities in the medical device arena. The ideal candidate will ensure the Company adheres to FDA quality and regulatory guidelines.Assist with product complaints and MDR management system, quality metrics, reporting, perform product inspections and QSR audits, good documentation practices, issue audit reports and special projects.Assist with international registrations projects coordinating with government entities.Interface with sales administration on vendor compliance issues.Assist in maintenance of quality systems to ensure compliance with ISO, QSR and Corporate requirements.Assist with CAPA and inspection activities.Responsible for document control to include writing procedures. Excellent understanding of documentation (good documentation practices) required in a medical device/pharma environmentEnsure that all Design History projects comply with regulatory, developer, and company requirements for HS products.Assist in training staff on pertinent regulatory and pertinent issues, as assigned by department senior staff. Topics include inspections, document compliance, etc.Conduct and/or participate in specialized audits, i.e.: documentation, integration, CAPA, procedure manuals, labeling, etc.Coordinate department annual records retention projects to ensure compliance with regulatory requirementsConduct product inspections, i.e.: receiving and integration with department administrative staffParticipate in company Quality Management Review meetingsAssist department and senior management and participates in regulatory investigations.
Participation includes, but is not limited to: answering questions on documentation, taking inspection notes with Inspection Coordinator, identification of relevant inspection documents, etc.Assist with Complaint integrations into Complaint databaseInitiate and/or assist with trending of documentation metrics for company Management Review and additional meeting forums Bachelor’s degree in a science discipline preferred. Experience with digital radiography and/or opthalmic products preferred.Min. 1 year of RA/QS experience in a FDA regulated environment is required, including complaint management and documentation.Familiar with FDA, QSR and ISO standards.Excellent written and verbal communication skills.Intermediate MS office computer skillsExperience interfacing with regulatory agencies, i.e., FDA is highly desirableAbility to provide routine trending on documentation projects, as requiredIf you are not reviewing this job posting on our Careers’ site https://www.usa.canon.com/internet/portal/us/home/about/careers, we cannot guarantee the validity of this posting. For a list of our current postings, please visit us at https://www.usa.canon.com/internet/portal/us/home/about/careers.
“medical device” MDR CAPA