the smart solution for Austin jobs

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


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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

VP of Product Management
Description: Overview br br Company is seeking an experience product executive to lead product management for our Core IT portfolio of products. br br Responsibilities Drive a security product strategy to (more...)
Company: Software Services, Austin, TX
Location: Austin
Posted on: 04/20/2019

Operations Manager - Restaurant
Description: OverviewGENERAL SUMMARYThe Shift Manager - He/she has the primary responsibility for managing shifts conveying the Cane's culture to his/her Crewmembers and Customers as well be a creative team player (more...)
Company: Raising Cane's
Location: Austin
Posted on: 04/19/2019

Construction Integration Manager
Description: Top 20 nationwide general contractor seeks a Regional Integration Manager who evaluates, designs, executes, measures, monitors and controls technology based business processes. Will work to ensure that (more...)
Company: Job Juncture
Location: Austin
Posted on: 04/19/2019

11B Infantryman - Management Training
Description: The Infantry is the backbone of the Army. These Soldiers fill the literal boots on the ground who are responsible for taking or holding ground during any combat operation. You'll attack, repel, and capture (more...)
Company: Army National Guard
Location: San Antonio
Posted on: 04/20/2019

Vice President Transportation
Description: VIA Metropolitan Transit, in San Antonio, is hiring a Vice President Transportation. VIA was named the Outstanding Metropolitan Transit Agency for 2017 by the Texas Transit Association. VIA is focused (more...)
Company: VIA Metropolitan Transit
Location: San Antonio
Posted on: 04/20/2019

Project Manager
Description: We Are Hiring Project Manager - Executive Support 001 - Full-Time,Day - Seton Administrative Offices - Austin,TXWhy Join Ascension At Seton, we're using the power of purpose to change healthcare for (more...)
Company: Ascension
Location: Austin
Posted on: 04/20/2019

Executive Director, Marketing and Communications
Description: Job location: San Antonio TAMUSA Employment Type: Full-time Posted data: 2019-04-08 Req: R-017890 Job Title Executive Director, Marketing and Communications Agency Texas A M University - San Antonio Department (more...)
Company: Texas A&M University San Antonio
Location: San Antonio
Posted on: 04/20/2019

Care Manager II (RN)
Description: Description: Position Purpose : Perform care management duties to assess, plan and coordinate all aspects of medical and supporting services across the continuum of care for select members to promote (more...)
Company: Centene Corporation
Location: Austin
Posted on: 04/19/2019

Terminal Manager - 5+ yrs previous EXP in Ops/ Logistics - Lockhart, T
Description: Terminal Manager In the role as a Terminal Manager the candidate will be a salary, exempt employee who, under the supervision of a General Manager, is responsible for the overall operations of the bus (more...)
Company: Student Transportation of America
Location: Fischer
Posted on: 04/20/2019

Terminal Manager - 5+ yrs previous EXP in Ops/ Logistics (Maxwell,TX)
Description: Terminal Manager In the role as a Terminal Manager the candidate will be a salary, exempt employee who, under the supervision of a General Manager, is responsible for the overall operations of the bus (more...)
Company: Student Transportation of America
Location: Maxwell
Posted on: 04/19/2019

Log In or Create An Account

Get the latest Texas jobs by following @recnetTX on Twitter!

Austin RSS job feeds