Leader Specialist, Quality Systems and Quality Assurance

Duties and Responsibilities

Quality Assurance/Quality Management System (Primary and Essential 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 3^rd-party logistics company and then perform the shipment permission inspection on products that are to be shipped from the 3^rd-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 if required.

• 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.

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.

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.

Knowledge and Skills

• Bachelor’s Degree in chemistry, biology, engineering or other technical field required.

• Two or more years of experience working in a regulated diagnostic industry required.

• Senior roles will require seven or more years of experience working in a regulated diagnostic industry required.

• Experience working with Class I and Class II medical devices, preferably laboratory, and Point of Care IVD instruments and reagents that are subject to US regulatory submission.

• Knowledge and working experience on FDA, GMP/QSR, ISO, CFR and/or other regulatory issues related to medical devices.

• Senior roles will require the ability to manage both undergoing ISO 13485 audits and conducting supplier audits in compliance with ISO 13485 standards.

• Knowledge on US regulatory submissions. Ability to build direct relationships and deal with the FDA in relation to the submission process is preferred.

• Clinical study management experience is preferred.

• Experience in quality systems and quality assurance activities.

• Proficiency in Microsoft Office programs (including, but not limited to Word, Adobe, Excel, PowerPoint)

• Ability to travel.

Physical Requirements

Heavy keyboarding / PC use

ARKRAY is an Equal Opportunity Employer: minorities, women, veterans, and individuals with disabilities.