Sr. Quality Engineer (CDx)

Job Description

The Sr. Quality Engineer plays an integral role in supporting quality activities related to IVD product development following FDA, ISO, and CMDR regulations. This role will ensure that design control requirements are implemented and followed, support multiple product development projects, and ensure that quality objectives are met during the product development life cycle. The Quality Engineer also supports the company’s quality system activities that comply with the FDA’s Quality System Regulation and ISO 13485 and CLIA, CAP, and applicable state requirements.

The primary point of contact for all quality activities related to the Guardant Health IVD development activities include guiding Design Controls, Risk Management, and decisions on product development activities to ensure continued compliance with internal procedures and applicable regulations

• Guides stability testing, sample plan definition, verification, and validation study development
• Ensures required documentation is completed before product transfers and product launches
• Provides guidance on cross-functional teams responsible for the 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
• Performother 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’sdegree in Chemistry, Biology, Engineering or a related scientific discipline
• 5+ years of quality experience in an FDA/ISO regulated and IVD/Biotech environment
• Experience in supporting analytical validation and clinical validation studies is a must
• Experience inmolecular biology products or molecular diagnostic products is desirable
• Ability to understand design changes/ design lock
• Knowledge of applying statistical analysis for testing, process control, and design of experiments
• Strong team player with a 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 interpersonal skills
• ASQ CQE certification preferred

Employees 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.

Additional Information

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.