ABOUT US:
Biodesix is a leading diagnostic company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix is the first company to offer six non-invasive tests for patients with diseases of the lung. The blood based Biodesix Lung Reflex® strategy for lung cancer patients integrates the GeneStrat® and VeriStrat® and NGS tests to support treatment decisions with results in 72 hours, expediting time to treatment. The blood based Nodify Lung™ nodule risk assessment testing strategy consisting of the Nodify XL2™ test and the Nodify CDT™ test evaluates the risk of malignancy in incidental pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. Biodesix also collaborates with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease. For more information about Biodesix, please visit www.biodesix.com.

OBJECTIVE OF THE POSITION:
The objective for this position is to work collaboratively with cross-functional teams to ensure the production of innovative diagnostic tests that meet FDA cGMP regulations and comply with the company's high standards of quality. The successful candidate will take ownership of initiating and completing quality documentation for kit builds, conduct product acceptance testing, maintain accurate inventory counts, and provide support for the efficient operation of the KanBan system for Manufacturing inventory. Additionally, the candidate will maintain a clean and organized work area, adhere to daily contamination controls, and respond quickly to environmental alerts. Finally, the candidate will be flexible and willing to take on other duties as assigned to support the success of the Manufacturing team.

REGULATORY REQUIREMENTS:
This role shall comply, at a minimum, with the responsibilities and qualifications outlined in:

• ISO: International Organization for Standardization (ISO) 13485, Quality Management Systems, Requirements for Regulatory Purposes, 2016
• QSR: Quality System Regulation, Title 21 Code of Federal Regulations Part 820
• All other applicable state and regulatory governing authorities including but not limited to: CA, PA, RI, MD applicable state and regulatory governing authorities including but not limited to: CA, PA, RI, MD

COMPENSATION RANGE:
$19.57 - $21.73 an hour

OTHER:
This position is eligible for both annual equity awards and our short-term incentive program. Biodesix provides paid healthcare, including medical, dental and vision, and a competitive paid vacation and sick leave program.
Please visit our website for additional details. www.biodesix.com/careers/benefits

Biodesix 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, disability, or veteran status.