Quality Assurance & Regulatory Affairs Manager
Location: Cedar Creek
Posted on: April 19, 2019
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.
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
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
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
Conducts internal Quality Assurance compliance audits and
Interfaces with external auditing entities and communicates
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
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
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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