Now Hiring - ARKRAY - Assistant Manager, Quality Systems and Quality Assurance in Doral, FL

Full description of the position

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. Duties and Responsibilities Regulatory (Supporting Responsibility) * 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. 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. 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.*ARKRAY offers a generous benefit package that includes Medical, Dental, Vision, 401K w/company match, FSA and HSA options.*