Senior Quality Engineer, Design Control (IVDD/IVDR)

Job Description

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

Work Environment:

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.

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