Abrar Admin

ARKRAY USA

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 Summary
 
 
 
 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.
 
 
 
 Essential Responsibilities
 
 
 
 
 Regulatory (Supporting Responsibility)
 
 
 
 <ul>
 <li>
 Actively engage in pre-/post-market regulatory activities, which include but are not limited to the following:
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 <li>
 Review and approval of product labeling.
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 <li>
 Review of FDA submissions.
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 <li>
 Assist/work with consultants as needed.
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 Support R&amp;D with 510(k) submissions.
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 <li>
 Create Regulatory Master Plans for product launches.
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 <li>
 Lead the development of new product labeling and oversee the labeling program to coordinate the review, approval, and tracking of all product labeling.
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 Act as the subject matter expert on UDI.GUDID regulations.
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 <li>
 Manage FDA facility registrations and device listings.
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 <li>
 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.
 </li>
 <li>
 Write Health Risk Assessments for Nonconforming products, customer complaints and MDRs.
 </li>
 <li>
 Review ECRs.
 </li>
 <li>
 Support Sales and Marketing to resolve any FDA compliance questions or concerns from customers.
 
 
 </li>
 </ul>
 
 Science (Supporting Responsibility)
 
 
 
 <ul>
 <li>
 Support Medical Lab Scientists of the Smart Assist project.
 </li>
 <li>
 Support clinical studies as needed. Including but not limited to hands-on assistance in the clinical studies.
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 <li>
 Train and support the Clinical Application Specialists and Field Service Engineers in their activities.
 </li>
 <li>
 Perform other pre-/post-market activities as assigned.
 
 
 </li>
 </ul>
 
 Quality Assurance/Quality Management System (Primary Responsibility)
 
 
 
 <ul>
 <li>
 Manage the supplier databases for our major retail-chain partner.
 </li>
 <li>
 Manage the Validation Program, Change Control Review, and approve Supplier Change Requests.
 </li>
 <li>
 Coordinate the review, approval, and tracking of all Engineering Changes from our suppliers.
 </li>
 <li>
 Review and approve ECRs.
 </li>
 <li>
 Manage various Quality System databases.
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 Oversee software validations.
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 <li>
 Fulfill the role of internal auditor. Also, manage the Internal Audit Program.
 </li>
 <li>
 Prepare supplier audits and scorecards. Also, manage the Supplier Approval Program.
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 Conduct External Audits.
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 Assemble the monthly AOD presentation materials and present the training data.
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 <li>
 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.
 </li>
 <li>
 Act as the Quality Plan Manager for Product Launches if required.
 </li>
 <li>
 Ensure compliance with FDA QMSR, ISO 13485, and OSHA.
 </li>
 <li>
 Fulfill the role of OSHA Safety Coordinator for our Miami Facility and any new facilities that may be added in the future.
 </li>
 <li>
 Fulfill the role of CAPA Manager for CARs, SCARs, and ISCARs if required.
 </li>
 <li>
 Chair the monthly AOD (Analysis of Data) meeting if required.
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 <li>
 Prepare and present CAPA data at the monthly meeting if required.
 
 
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 </ul>
 
 Complaint Handling (Supporting Responsibility)
 
 
 
 <ul>
 <li>
 Oversees Post Market Surveillance - Customer Complaints.
 </li>
 <li>
 Create the Monthly Risk Review Report.
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 Manage Product Recalls and other field actions.
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 Manage our Lab Division&rsquo;s Complaint Program and coordinate External Complaint with AFC (factory headquarters in Japan).
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 Chair the Lab Division&rsquo;s monthly Complaint Meeting.
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 <li>
 Present the Lab Division&rsquo;s Complaints in the monthly AOD meeting.
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 Review Technical Bulletins.
 </li>
 <li>
 Manage the Healthcare Division&rsquo;s Complaint Program.
 </li>
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 Chair the Healthcare Division&rsquo;s monthly Complaint Meeting.
 </li>
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 Present the Healthcare Division&rsquo;s Complaints in the monthly AOD meeting.
 </li>
 <li>
 Submit MDRs to the FDA.
 </li>
 <li>
 Create the Monthly Vendor Reporting.
 </li>
 <li>
 Review the Daily Call Data of our major retail-chain partner.
 
 
 </li>
 </ul>
 
 General Duties
 
 
 
 <ul>
 <li>
 Act as the Facilities and Equipment Manager of our Miami location.
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 <li>
 Pick up and process company mail.
 </li>
 <li>
 Coordinate activities for the Miami Facility and Office.
 
 
 </li>
 </ul>
 
 This job description is not intended to be all-inclusive and the employee will also perform other reasonably related business duties as assigned by management.
 
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Assistant Manager, Quality Systems and Quality Assurance

Join ARKRAY USA and explore 1   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

ARKRAY USA

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Assistant Manager, Quality Systems and Quality Assurance