Senior Quality Engineer
Senior Quality Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
The Senior Quality Engineer plays a critical role in ensuring the quality and compliance of Guardant Healths in vitro diagnostic (IVD) products throughout the product lifecycle from development to manufacturing and supplier interactions. This role is a primary quality liaison for reagent development providing expert guidance on Design Controls Risk Management Change Control and Validation activities. The Senior Quality Engineer supports and enhances the Quality Management System (QMS) in accordance with FDA regulations 21 CFR 820 ISO 13485 CLIA CAP CMDR and other applicable standards. Additionally this role drives continual improvement initiatives collaborates with crossfunctional teams to ensure the successful launch of new products and collaborates with ongoing quality of innovative healthcare solutions.
Essential Duties and Responsibilities:
- Develops and applies quality requirements for Guardant Healths reagent manufacturing process and quality control activities. This includes providing guidance for Production and Process Controls Risk Analysis and decisions on process validation activities
- Define and provide guidance for statistical methodologies sampling plans and stability testing requirements
- Ensures required documentation is completed prior to product transfers and product launches
- Leads all risk management and change control activities related to reagents
- Provides guidance on process and test method validations revalidations and participates in related change control activities
- Support internal audits CAPAs nonconformance investigations and supplier quality activities
- Supports equipment qualification (IQ OQ PQ)
- Supports review of manufacturing records and material disposition as required
- Support material related issues and deviations
- Identifies opportunities for continuous improvement and collaborates with crossfunctional teams to successfully address these opportunities
- Use Statistical Process Control (SPC) to ensure product quality to identify areas for improvement and to reduce variability and defects
- Generate metrics as required and report to management
- 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. degree in Engineering Biology Chemistry Molecular Biology or a related scientific discipline
- 5 years of quality experience in an FDA/ISO regulated environment (IVD molecular diagnostics or medical devices preferred)
- Working knowledge of design and development in accordance with ISO 13485/FDA 21 CFR 820 and other applicable regulations
- Experience with Design Controls Risk Management Process Validation and Change Control
- Experience with design control elements and design transfer
- Handson experience with statistical methods sampling plans Statistical Process Control (SPC) and Design of Experiments (DoE)
- Knowledge of Good manufacturing practices
- Knowledge of Design for Manufacturing (DFM) leading to more efficient and costeffective production
- Ability to successfully balance and prioritize multiple ongoing projects/tasks in a fastpaced deadline driven environment
- Strong analytical and problemsolving skills; attention to detail is essential
- Proficient verbal and written communication; able to communicate effectively with crossfunctional stakeholders
- Collaborative and selfmotivated mindset with a drive for results and process improvement
Additional Information :
Hybrid Work Model: At Guardant Health we have defined days for inperson/onsite collaboration and workfromhome days for individualfocused 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 inoffice 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 worklife 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 fulltime 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 jobrelated 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 longterm 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 :
No
Employment Type :
Fulltime
Employment Type
Full-time
