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Audit / Quality Manager

Company: Agilent
Location: Santa Clara
Posted on: May 8, 2022

Job Description:

As a federal contractor and healthcare company committed to protecting the health and safety of our employees, contractors, customers and communities, employees in the U.S. and Puerto Rico are required to be fully vaccinated against COVID-19, unless an approved exemption has been granted for a medical reason, sincerely held religious belief, or an employee is otherwise exempt under applicable law. Agilent encourages and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek so they can do what they do best: improve the world around us. Want more info on Agilent? Check outwww.agilent.com The Quality Assurance and Regulatory Affairs Manager will play a key role with our new product introduction team for genomics products that are taken from concept, design, development to commercialization. The genomics and genetic testing products consist of reagents, microarrays, instruments and bioinformatics software. The RAQA Manager will ensure compliance with industry guidelines, regulatory standards and company requirements related to manufacturing of microarrays and oligo products. Responsibilities will also include working with team members such as Marketing, R&D, Manufacturing, Support and Clinical as well as outside organizations such as suppliers, test facilities and regulatory bodies. Develops, implements, and maintains Quality Management system and activities within FDA, ISO 13485 and international regulatory guidelines for Santa Clara and La Jolla sites Serves as site management representative with responsibility for reporting on the performance of the quality objectives and any need for improvement to top management. Conducts internal Quality Assurance compliance audits and communicates results. Works with external auditing entities, communicates results, and responds to findings. Participates and leads microarray and oligo manufacturing, complaints, post market surveillance, and CAPAs Review and approve change requests, change orders. nonconformance, and deviations Develops, modifies, and executes company regulatory guidelines, global and business procedures Create and / or update design and process FMEA. Review, create, and / or update traceability matrices Evaluates contract manufacturer(s) to meet the company's quality requirements Manage a team of QA engineers for commercialization of new genomics products. Interpret Regulatory Authority policies, guidance and correctly applies them as appropriate in product development. Assist in RA filings (Pre-sub, IDE, PMA, 510k, design dossiers) to promote successful product regulatory submissions and increase probability of regulatory approval. Assist in development and execution of regulatory plans for complex projects. Assist in documentation for regulatory meetings with FDA. Ensures the promotion of awareness of customer, quality, and regulatory requirements throughout the organization Monitor applicable regulatory requirements; assure compliance with internal procedures and external standards Ensure project teams and business objectives and deliverables are aligned with regulatory strategy Assist with the verification and validation experimental design; coordinate with regulatory affairs and R&D and manufacturing to confirm experimental design conforms to appropriate regulatory requirements. Conduct detailed reviews and identify gaps and update Design History Folders (DHF) and Device Master Records (DMR) for the existing products. As needed, coordinate with production manufacturing to bring device master record documentation to QSR levels. Provide quality and regulatory training to company staff PDN-9636de3f-7bbe-4e22-9367-dca895994056

Keywords: Agilent, Santa Clara , Audit / Quality Manager, Executive , Santa Clara, California

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