The Senior Quality Engineer 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:- Point of contact for all quality activities related to the Guardant Health IVD development and Operations activities which include providing guidance for Design Controls, Risk Management, and decisions on product development activities to ensure continued compliance with internal procedures and applicable regulations.
- Primary support for supplier management program and related activities which include supplier collaborations and agreements.
- Provides guidance on stability testing, sample plan definition, and validation study development.
- Provides guidance to qualifications and/or validations respective to equipment, facility, laboratory, and process.
- 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.
- Ability to lead Risk Management and Change Control activities.
- Support processes such as document control, training, CAPAs, nonconforming event, and developing Quality metrics.
- Identifies opportunities for continuous improvements and work with management and team members to successfully address these opportunities.
- Perform and document internal audits, make recommendations for corrective actions, and be able to conduct external audits.
- 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, Molecular Biology, or a related scientific discipline
- 5+ years of quality experience in a FDA/ISO regulated environment (IVD, molecular diagnostics, or medical devices preferred).
- Experience in molecular biology products or molecular diagnostic products
- Knowledge of applying statistical methods analysis for testing, process control, and design of experiments
- Hands-on experience with risk management, process validation, and change control
- Strong collaborator 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
- Knowledge of Good Manufacturing Practices.
- Working knowledge of ISO13485, 21CFR820, IVDD, CLIA and CAP requirements
- ASQ CQE certification preferred.
AI & Digital Fluency- Demonstrate curiosity, sound judgment, and the ability to critically evaluate and responsibly leverage AI-enabled tools in accordance with company policies, ethical standards, and regulatory requirements to improve the efficiency, effectiveness, and quality of work.
Hybrid Work Model:This section is applicable to onsite employees who are eligible for hybrid work location as specified by management and related policies. Guardant has 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.The annualized base salary ranges for the primary location and any additional locations are listed below. This range does not include benefits or, if applicable, bonus, commission, or equity. Each candidate's compensation offer will be based on multiple factors including, but not limited to, geography, experience, education, job-related skills, job duties, and business need.Primary Location: Redwood City, CAPrimary Location Base Pay Range: $114,600 - $157,600Other US Location(s) Base Pay Range: $97,410 - $133,960If the role is performed in Colorado, the pay range for this job is: $103,140 - $141,840
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.
