Assistant Manager, Quality Systems and Quality Assurance

ARKRAY GROUP•Doral, FL

165d•Onsite

About The Position

This role requires the ability and knowledge to conduct work in at least one of the five major job duties and responsibilities (excluding General Duties), contributing to company compliance with relevant laws and regulations. The position involves active engagement in pre-/post-market regulatory activities, quality assurance, quality management systems, and complaint handling. It also includes general duties such as facilities and equipment management.

Requirements

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.
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.
Knowledge on US regulatory submissions.
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.

Nice To Haves

Senior roles will require seven or more years of experience working in a regulated diagnostic industry required.
Ability to build direct relationships and deal with the FDA in relation to the submission process is preferred.
Clinical study management experience is preferred.
Senior roles will require the ability to manage both undergoing ISO 13485 audits and conducting supplier audits in compliance with ISO 13485 standards.

Responsibilities

Actively engage in pre-/post-market regulatory activities, including review and approval of product labeling, FDA submissions, and supporting R&D with 510(k) submissions.
Create Regulatory Master Plans for product launches and lead the development of new product labeling.
Act as the subject matter expert on UDI and 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.
Support Sales and Marketing to resolve any FDA compliance questions or concerns from customers.
Support Medical Lab Scientists of the Smart Assist project and clinical studies.
Train and support the Clinical Application Specialists and Field Service Engineers.
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.
Manage various Quality System databases and oversee software validations.
Fulfill the role of internal auditor and manage the Internal Audit Program.
Prepare supplier audits and scorecards, and 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 and shipment permission inspections.
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.
Fulfill the role of CAPA Manager for CARs, SCARs, and ISCARs if required.
Chair the monthly AOD (Analysis of Data) meeting if required and prepare/present CAPA data.
Oversee 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.
Chair the Lab Division’s monthly Complaint Meeting and present Lab Division’s Complaints in the monthly AOD meeting.
Review Technical Bulletins.
Manage the Healthcare Division’s Complaint Program and chair its 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.