Quality Assurance Manager

Company: MPS Medical, Inc.
Location: Brea
Posted on: February 22, 2021

Job Description:

Company DescriptionOn December 31st, 2020 Innova Medical, Inc. acquired MPS Medical to expand its U.S production of COVID-19 antigen test kits, producing over 4 million SARS-CoV-2 Antigen Rapid Qualitative Tests per day. Currently, Innova Medical Group, Inc. is the world's largest manufacturer of rapid antigen test kits and leader in COVID-19 testing solutions arena.Innova Medical Group, Inc. achieves to deliver better global health outcomes with its deep expertise in testing and unique offerings in diagnostic medical devices and services that help tackle some of the world's most challenging healthcare problems. Alongside of COVID-19 solutions, Innova specializes in innovative screening, testing and diagnostics for cancer, heart disease, arterial calcification, stroke, and virus detection focused on infectious disease.In this role coordinates activities related to production, personnel handling, quality assurance, material requesting and internal customer service in product manufacturing. This includes activities area assigned in the clean room and packaging areawww.innovamedgroup.comwww.mpsmedical-inc.comJob Description* Support Site Operations, Quality, and R&D teams by addressing issues and opportunities that might arise. The Quality Manager will serve as the quality representative during any product or process investigation including root cause analysis and health risk assessment of the identified product or process nonconformities.* Prepare and execute validations, technical studies, test method validations and other studies / reports as required. This includes preparation of protocols, establishment of test methodology and acceptance criteria, training personnel, execution, data analysis, investigation, and writing final reports.* Initiate and lead project teams on non-conformance investigations regarding component failures, finished goods failures, and product returns. This includes but is not limited to performing risk analysis, determining root cause and recommending corrective action.* Conduct internal audits and supplier audits. This includes preparation of audit plans, audit reports, and verifying corrective actions have been completed and are effective. Act as Management representative for FDA and ISO audits.* Lead assigned Corrective Action/Preventive Action (CAPA) projects. This includes, but is not limited to, performing risk analysis, root cause analysis; developing a corrective action plan, implementing the plan, and submitting a summary report for project closure and conduct effectively checks (EC).* Manage customer complaints and product returns including investigations to determine root cause is product related as well as corrective actions.* Ensure Regulatory Compliance by managing and update internal procedures with new standard updates. Continuously work to align procedures with current practices.* Generate and update work instructions and SOP's to standardize documentation processes.Qualifications* 6-10 years of experience working in a medical Device manufacturing quality role some in management.* Proficient in Risk Management - ISO 14971:2012 and FDA QSR, ISO 13485:2016* ASQ certification a plus.* Knowledge of European device requirements a plus.* Hands-on experience with development of quality plans, design control documents, management of DMR and DHR's, problem solving, statistical methods, test protocols, technical reports, risk analysis and data analysis.* Thorough knowledge of FDA and ISO standards and managing associated quality systems.* Experience working with interdisciplinary including management, marketing, engineers, and vendors.Additional InformationPHYSICAL DEMANDS -Reasonable accommodations may be made to enable individuals with disabilities to perform the following essential physical demands:* Physically able to sit, stand and walk for extended periods of time.* Able to move about on foot; walk up and down stairs repeatedly as needed.* Clarity of vision at 20 inches or more; able to view a computer monitor for extended periods of time.

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