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ARKRAY GROUP

Discussion

Assistant Manager, Quality Systems and Quality Assurance

Open 33d

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)

  • Actively engage in pre-/post-market regulatory activities, which include but are not limited to the following:

  1. Review and approval of product labeling.

  2. Review of FDA submissions.

  3. Assist/work with consultants as needed.

  4. 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.

Science (Supporting Responsibility)

  • 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.

Quality Assurance/Quality Management System (Primary Responsibility)

  • 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.

Complaint Handling (Supporting Responsibility)

  • 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.

General Duties

  • 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.

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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