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Senior Quality Engineer

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1 Vacancy
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Job Location drjobs

Redwood City - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

The Senior Quality Engineer Reagents plays a critical role in ensuring the quality and compliance of Guardant Healths in vitro diagnostic (IVD) products across the product lifecycle from early design and development to manufacturing and supplier collaboration. This role serves as a primary quality liaison for reagent development offering expert guidance on Design Controls Risk Management Process Validation and Change Control. The Senior Quality Engineer also supports the Quality Management System (QMS) in alignment with FDA regulations (21 CFR 820) ISO 13485 CLIA CAP and other global standards. The ideal candidate will have a strong background in process validation and equipment qualification in a reagent manufacturing environment drive continuous improvement ensure design robustness and enable seamless design transfer of high-quality compliant reagent products.  
 

Essential Duties and Responsibilities: 

  • Lead Design Quality Engineering efforts for reagent product development including phase design reviews risk assessments and design verification/validation. 
  • Define and apply quality requirements for reagent manufacturing processes and quality control activities. 
  • Provide guidance on Production and Process Controls sampling plans and reagent stability testing requirements. 
  • Lead Risk Management activities per ISO 14971 and ensure effective integration into design and process decisions. 
  • Lead Change Control assessments related to reagent formulations manufacturing process changes reagent qualification changes and supplier updates. 
  • Support design transfer from development to manufacturing ensuring readiness and compliance for commercial scale-up. 
  • Support equipment qualification (IQ/OQ/PQ) and test method validation for reagent manufacturing and quality control. 
  • Collaborate with Technical Development Operations Quality Control and Regulatory Affairs teams to proactively address quality issues in design and manufacturing. 
  • Conduct and document internal audits manage CAPAs and support nonconformance investigations related to reagents. 
  • Promote a culture of quality and compliance through training mentoring and cross-functional engagement. 
  • Performs 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 :

  • B.S. in Engineering Biology Chemistry Molecular Biology or a related scientific discipline. 
  • Minimum 5 years of Quality Engineering experience in FDA/ISO regulated environment (IVD medical devices or reagent-based preferred). 
  • Deep knowledge of Design Controls Risk Management Validation and Design Transfer. 
  • Strong understanding of ISO 13485 FDA 21 CFR 820 and applicable global regulations. 
  • Experience in statistical analysis Design of Experiments (DoE) and sampling plans for reagent processes. 
  • Working knowledge of GMPs reagent formulation and stability testing. 
  • Ability to support multiple projects with cross-functional stakeholders in a fast-paced environment.  
  • Excellent problem-solving analytical and communication skills. 


Additional Information :

Hybrid Work Model: At Guardant Health we have defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays Tuesdays and Thursdays. We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant our work model has created flexibility for better work-life balance while keeping teams connected to advance our science for our patients.

For positions based in Redwood City CA the base salary range for this full-time position is $112700 to $155000. The range does not include benefits and if applicable bonus commission or equity.

Within the range individual pay is determined by work location and additional factors including but not limited to job-related skills experience and relevant education or training. If you are selected to move forward the recruiting team will provide details specific to the factors above.

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 committed to providing reasonable accommodations in our hiring processes for candidates with disabilities long-term conditions mental health conditions or sincerely held religious beliefs. If you need support please reach out to 

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.

Please visit our career page at:  Work :

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Employment Type :

Full-time

Employment Type

Full-time

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