RedwoodCityRecruiter Since 2001
the smart solution for Redwood City jobs

Senior Quality Engineer, Design Control (IVDD/IVDR)

Company: Guardanthealth
Location: Redwood City
Posted on: September 16, 2020

Job Description:

Senior Quality Engineer, Design Control (IVDD/IVDR) Full-time

Company Description Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs. In pursuit of its goal to manage cancer across all stages of the disease, Guardant Health has launched multiple liquid biopsy-based tests, Guardant360® and GuardantOMNI® , for advanced stage cancer patients, which fuel its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection. Since its launch in 2014, Guardant360® has been used by more than 7,000 oncologists, over 50 biopharmaceutical companies and all 27 of the National Comprehensive Cancer Network centers.

Job Description This role works out of our  Headquarters in Redwood City, CA .  Due to the Covid 19 Pandemic Guardant Health has temporarily classified this role as ‘working from home status’, scheduled to return onsite at HQ when it is determined safe to do so.

The Senior Quality Engineer (IVDD-IVDR) plays an integral role in supporting quality activities related to IVD product development in accordance with FDA, ISO, and CMDR regulations. The Quality Engineer also supports the company’s quality system activities that comply with the FDA’s Quality System Regulation and ISO 13485 as well as CLIA, CAP, and applicable state requirements.

Essential Duties and Responsibilities:

Primary point of contact for all quality activities related to the Guardant Health IVD development activities which includes providing guidance for Design Controls, Risk Management, and decisions on product development activities to ensure continued compliance with internal procedures and applicable regulations

Provides guidance on stability testing, sample plan definition, and validation study development

Ensures required documentation is completed prior to product transfers and product launches

Provides guidance on cross-functional teams responsible for implementation of new products, process improvements, and troubleshooting activities

Leads all Risk Management and Change Control activities

Support processes such as document control, training, CAPAs, and developing Quality metrics

Identifies opportunities for continual improvement and works with management and team members to successfully address these opportunities

Perform and document internal audits and make recommendations for corrective actions

Perform other related duties and responsibilities as assigned

Report and document all concerns of test quality and/or safety to the Supervisor or Safety Officer, as applicable.

Qualifications Bachelor’s degree in Chemistry, Biology, Engineering or a related scientific discipline

5+ years of quality experience in a FDA/ISO regulated environment

Experience in molecular biology products or molecular diagnostic products or IVD

Knowledge of applying statistical analysis for testing, process control, and design of experiments

Strong team player with demonstrated track record

Ability to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment

Excellent problem-solving and analytical skills

Effective communication and inter-personal skills

ASQ CQE certification preferred

Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and bio-hazard material in the laboratory environment. Ability to sit for extended periods of time.

Additional Information Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.

Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

All your information will be kept confidential according to EEO guidelines.

To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our  Privacy Notice for Job Applicants .

Senior Quality Engineer, Design Control (IVDD/IVDR)

Keywords: Guardanthealth, Redwood City , Senior Quality Engineer, Design Control (IVDD/IVDR), Other , Redwood City, California

Click here to apply!

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

I'm looking for
in category
within


Other Other Jobs


FedEx Operations - Packaging
Description: Auto req ID: 248748BRJob SummaryFedEx Ground is an essential business that needs people to help us support the economy, handling life-saving medications and other items that keep our communities as prepared (more...)
Company: FedEx Ground PH US
Location: West Sacramento
Posted on: 09/20/2020

In-Store Shopper (Part-Time/ Flexible Hours)
Description: Warehouse/Shopper Team Member Part-Time, Flexible Hours br br Shifts: br Morning, Day, Evening, Weekend br br Flexible Shift Requirements br All br flexible shift associates will start (more...)
Company: Amazon
Location: Santa Cruz
Posted on: 09/20/2020

Amazon Online Order Shopper - Part Time
Description: Warehouse/Shopper Team Member Part-Time, Flexible Hours br br Shifts: br Morning, Day, Evening, Weekend br br Flexible Shift Requirements br All--flexible shift associates will start on (more...)
Company: Amazon Workforce Staffing
Location: Santa Cruz
Posted on: 09/20/2020


Amazon Workforce Staffing: Seasonal Part-Time Warehouse Team Member - $500 Sign-On Bonus
Description: Seasonal Part-time Warehouse Team Member 500 sign-on bonusHourly pay rate: Earn 15.50- 18.50/hr, plus benefits and a 500 bonus The base pay for this role is 15.00/hr. We are offering temporary shift (more...)
Company: Amazon Workforce Staffing
Location: Woodland
Posted on: 09/20/2020

High Demand For Quality Remodelers - Get New Clients In Your Area
Description: Over 25 million homeowners have trusted HomeAdvisor 1800Contractor to help them find quality professionals with the expertise to turn their home improvement
Company: HomeAdvisor
Location: Woodland
Posted on: 09/20/2020

Amazon Shopper (Part-Time/ Flexible Hours) - Earn up to $16.4/hr
Description: Warehouse/Shopper Team Member Part-Time, Flexible Hours br br Shifts: br Morning, Day, Evening, Weekend br br Flexible Shift Requirements br All --flexible shift associates will start on (more...)
Company: Amazon
Location: Santa Cruz
Posted on: 09/20/2020

Flex Power Equipment Operator - SMF1 - Make up to $23.25 per hour!
Description: Position Description br This role may be required to drive powered equipment, however no experience is required as we provide training on-site. br br Starting Base Pay: 16.25 br Walmart is rolling (more...)
Company: Walmart
Location: West Sacramento
Posted on: 09/20/2020

Amazon Workforce Staffing: In-Store Shopper
Description: Warehouse/Shopper Team Member Part-Time, Flexible Hours Shifts: Morning, Day, Evening, WeekendFlexible Shift RequirementsAllflexible shift associates will start on a standard training schedule for 1 (more...)
Company: Amazon Workforce Staffing
Location: Santa Cruz
Posted on: 09/20/2020

70120-Merchandise Associate
Description: 70120-Merchandise AssociateApply now --Apply now Start apply with LinkedIn Start apply with Xing Apply NowStart Please wait...Date:Sep 11, 2020Location:Woodland, CA, USCompany:TJX Companies, Inc.All (more...)
Company: TJX
Location: Woodland
Posted on: 09/20/2020

High Demand For Quality Siding Pros - Get New Clients In Your Area
Description: Over 25 million homeowners have trusted HomeAdvisor 1800Contractor to help them find quality professionals with the expertise to turn their home improvement
Company: HomeAdvisor
Location: Woodland
Posted on: 09/20/2020

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Redwood City RSS job feeds