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Quality Assurance & Regulatory Affairs Manager

Company: Agilent
Location: Cedar Creek
Posted on: April 19, 2019

Job Description:

Agilent inspires 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. Information about Agilent is available at www.agilent.com.

Responsibilities:

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, and development to commercialization. The genomics and genetic testing products consist of reagents, microarrays, instruments and bioinformatics software. The QA Manager will ensure compliance with industry guidelines, regulatory standards and company requirements. Responsibilities will also include interfacing 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.

Serves as site management representative with responsibility for reporting on the performance of the quality system and any need for improvement to top management.

Serve as the quality representative for new product introduction and new product improvement projects for all product types; participate in team meetings and coordinate quality activities as required.

Lead a team of QA engineers for design, development and commercialization of new genomics products.

Develops, modifies and executes regulatory related company guidelines and procedures.

Evaluates contract manufacturer(s) to meet the company's quality requirements.

Conducts internal Quality Assurance compliance audits and communicates results.

Interfaces with external auditing entities and communicates results.

Ensures the promotion of awareness of customer, quality and regulatory requirements throughout the organization.

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.

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.

Review and approve change requests and Change Orders.

Assist with the verification and validation experimental design; coordinate with regulatory affairs and R&D to confirm experimental design conforms to appropriate regulatory requirements.

Create and / or update design and process FMEA. Review, create, and / or update traceability matrices.

Conduct detailed reviews of all design history files; coordinate with project management, R&D, and manufacturing as needed ensure the project deliverables are complete, accurate, and in compliance with regulatory requirements. 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.

Keywords: Agilent, Austin , Quality Assurance & Regulatory Affairs Manager, Executive , Cedar Creek, Texas

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