The Sr. 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.
Primary point of contact for all quality activities related to the Guardant Health IVD development activities which includes providing guidance for Design Controls, Risk Analysis, 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 Change Control activities
Provides guidance on software development lifecycle activities and documentation.
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
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.
B.S. degree in Chemistry, Biology, Engineering or a related scientific discipline
7+ years of quality experience in a FDA/ISO regulated environment
IVD experience required
GCLP or GCP experience is a plus
Prior experience with software development for a medical device a plus
Experience in in molecular biology products or molecular diagnostic products
Knowledge of applying statistical analysis for 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
Internal Number: REF653R
About Guardant Health
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs. In pursuit of its goal to manage cancer across all stages of the disease, Guardant Health has launched multiple liquid biopsy-based tests, Guardant360 and GuardantOMNI, for advanced stage cancer patients, which fuel its LUNAR development programs for recurrence and early detection. Since its launch in 2014, Guardant360 has been used by more than 6,000 oncologists, over 50 biopharmaceutical companies and all 27 of the National Comprehensive Cancer Network centers.