Senior Quality Engineer, Supplier Management

Job Description

The Senior Quality Engineer, Supplier Management plays an integral role in supporting quality activities related to Supplier Management in accordance with FDA, ISO, and other IVD regulations. This individual 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.

• Responsible for maintenance and improvement of Guardant Health’s Supplier and Incoming Quality program
• Collaborate with supply chain to assess current suppliers and help in the selection of best-in-class suppliers
• Perform supplier quality audits to ensure that Guardant Health continuously receives high quality product and services
• Develop key supplier quality and incoming quality metrics and engage directly with the suppliers to drive quality and process improvements in order to continuously improve the quality of product and services received by Guardant Health
• Support incoming quality requirements including development of purchase specifications, sampling plans, incoming material approval, etc.
• Develop and maintain organized records that demonstrate compliance to all company processes, regulations, and the company’s QMS
• Represent Quality at cross functional meetings
• Support routine Quality processes such as document control, employee training, investigating non-conformances, Quality metrics, etc.
• Execute special projects as assigned

Qualifications

• Bachelor’s degree in engineering, biology or a related scientific discipline
• Certified Auditor preferred
• 5+ years of supplier quality experience in the Life Sciences Industry, with prior experience in an FDA regulated environment
• Working knowledge of medical device / in vitro diagnostic (IVD) regulations (e.g., FDA 21 CRF 820, ISO 13485, IVDD and other applicable quality and regulatory standards)
• Experience in all aspects of supplier quality, including supplier assessments/audits, maintaining a supplier evaluation program, supplier corrective actions and supplier process changes
• Effective verbal and written communication skills and ability to share and receive information from all levels of the organization throughout various departments
• Ability to constructively challenge concerns and engage in transparent conversations
• Ability to work effectively in a team environment
• Ability to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment
• Ability to identify, analyze and solve problems with minimal direction and escalate concerns to management
• Proven attention to detail and accuracy
• Effective organizational skills
• High degree of initiative and self-motivation
• Drive for results and continual improvement – Ensure procedures and processes are in place that lead to the delivery of quality results and continually assess their effectiveness to drive continual improvement
• Must be available to travel up to 25% of the 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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