ARKRAY USA · 1 month ago
Assistant Manager, Quality Systems and Quality Assurance
Doral, FL
Full-time
Onsite
Mid LevelARKRAY USA is seeking an Assistant Manager for Quality Systems and Quality Assurance. This role involves managing regulatory activities, quality assurance processes, and complaint handling to ensure compliance with relevant laws and regulations.
Health CareMedicalMedical Device
Responsibilities
Actively engage in pre-/post-market regulatory activities, which include but are not limited to the following:
Review and approval of product labeling
Review of FDA submissions
Assist/work with consultants as needed
Support R&D with 510(k) submissions
Create Regulatory Master Plans for product launches
Lead the development of new product labeling and oversee the labeling program to coordinate the review, approval, and tracking of all product labeling
Act as the subject matter expert on UDI.GUDID regulations
Manage FDA facility registrations and device listings
Manage FDA import inspections, provide FDA data and information to US Customs, and work with both the FDA and US Customs to resolve shipments placed on hold
Write Health Risk Assessments for Nonconforming products, customer complaints and MDRs
Review ECRs
Support Sales and Marketing to resolve any FDA compliance questions or concerns from customers
Support Medical Lab Scientists of the Smart Assist project
Support clinical studies as needed. Including but not limited to hands-on assistance in the clinical studies
Train and support the Clinical Application Specialists and Field Service Engineers in their activities
Perform other pre-/post-market activities as assigned
Manage the supplier databases for our major retail-chain partner
Manage the Validation Program, Change Control Review, and approve Supplier Change Requests
Coordinate the review, approval, and tracking of all Engineering Changes from our suppliers
Review and approve ECRs
Manage various Quality System databases
Oversee software validations
Fulfill the role of internal auditor. Also, manage the Internal Audit Program
Prepare supplier audits and scorecards. Also, manage the Supplier Approval Program
Conduct External Audits
Assemble the monthly AOD presentation materials and present the training data
Perform Quality Acceptance Inspections on products that are to be delivered to a 3rd-party logistics company and then perform the shipment permission inspection on products that are to be shipped from the 3rd-party logistics company
Act as the Quality Plan Manager for Product Launches if required
Ensure compliance with FDA QMSR, ISO 13485, and OSHA
Fulfill the role of OSHA Safety Coordinator for our Miami Facility and any new facilities that may be added in the future
Fulfill the role of CAPA Manager for CARs, SCARs, and ISCARs if required
Chair the monthly AOD (Analysis of Data) meeting if required
Prepare and present CAPA data at the monthly meeting if required
Oversees Post Market Surveillance - Customer Complaints
Create the Monthly Risk Review Report
Manage Product Recalls and other field actions
Manage our Lab Division’s Complaint Program and coordinate External Complaint with AFC (factory headquarters in Japan)
Chair the Lab Division’s monthly Complaint Meeting
Present the Lab Division’s Complaints in the monthly AOD meeting
Review Technical Bulletins
Manage the Healthcare Division’s Complaint Program
Chair the Healthcare Division’s monthly Complaint Meeting
Present the Healthcare Division’s Complaints in the monthly AOD meeting
Submit MDRs to the FDA
Create the Monthly Vendor Reporting
Review the Daily Call Data of our major retail-chain partner
Act as the Facilities and Equipment Manager of our Miami location
Pick up and process company mail
Coordinate activities for the Miami Facility and Office
Qualification
Required
Ability and knowledge to conduct the work listed in at least one of the 5 major job Duties and Responsibilities (excluding General Duties), so that they contribute to company compliance with relevant laws and regulations
Actively engage in pre-/post-market regulatory activities, which include but are not limited to the following: Review and approval of product labeling, Review of FDA submissions, Assist/work with consultants as needed, Support R&D with 510(k) submissions, Create Regulatory Master Plans for product launches, Lead the development of new product labeling and oversee the labeling program to coordinate the review, approval, and tracking of all product labeling, Act as the subject matter expert on UDI.GUDID regulations, Manage FDA facility registrations and device listings, Manage FDA import inspections, provide FDA data and information to US Customs, and work with both the FDA and US Customs to resolve shipments placed on hold, Write Health Risk Assessments for Nonconforming products, customer complaints and MDRs, Review ECRs, Support Sales and Marketing to resolve any FDA compliance questions or concerns from customers
Support Medical Lab Scientists of the Smart Assist project
Support clinical studies as needed. Including but not limited to hands-on assistance in the clinical studies
Train and support the Clinical Application Specialists and Field Service Engineers in their activities
Perform other pre-/post-market activities as assigned
Manage the supplier databases for our major retail-chain partner
Manage the Validation Program, Change Control Review, and approve Supplier Change Requests
Coordinate the review, approval, and tracking of all Engineering Changes from our suppliers
Review and approve ECRs
Manage various Quality System databases
Oversee software validations
Fulfill the role of internal auditor. Also, manage the Internal Audit Program
Prepare supplier audits and scorecards. Also, manage the Supplier Approval Program
Conduct External Audits
Assemble the monthly AOD presentation materials and present the training data
Perform Quality Acceptance Inspections on products that are to be delivered to a 3rd-party logistics company and then perform the shipment permission inspection on products that are to be shipped from the 3rd-party logistics company
Act as the Quality Plan Manager for Product Launches if required
Ensure compliance with FDA QMSR, ISO 13485, and OSHA
Fulfill the role of OSHA Safety Coordinator for our Miami Facility and any new facilities that may be added in the future
Fulfill the role of CAPA Manager for CARs, SCARs, and ISCARs if required
Chair the monthly AOD (Analysis of Data) meeting if required
Prepare and present CAPA data at the monthly meeting if required
Oversees Post Market Surveillance - Customer Complaints
Create the Monthly Risk Review Report
Manage Product Recalls and other field actions
Manage our Lab Division's Complaint Program and coordinate External Complaint with AFC (factory headquarters in Japan)
Chair the Lab Division's monthly Complaint Meeting
Present the Lab Division's Complaints in the monthly AOD meeting
Review Technical Bulletins
Manage the Healthcare Division's Complaint Program
Chair the Healthcare Division's monthly Complaint Meeting
Present the Healthcare Division's Complaints in the monthly AOD meeting
Submit MDRs to the FDA
Create the Monthly Vendor Reporting
Review the Daily Call Data of our major retail-chain partner
Act as the Facilities and Equipment Manager of our Miami location
Pick up and process company mail
Coordinate activities for the Miami Facility and Office
Company
ARKRAY USA
ARKRAY USA is a medical devices company specializing in HbA1c Analyzer and blood glucose monitoring system.
Founded in 1960
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Tadashi Inoue
Chief Executive Officer
Recent News
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