Quality Control Associate

Affimedix, a fast-growing Medical Device company in San Francisco Bay of California, focuses on R & D, product design, development, manufacturing and marketing of its “Proprietary” Point-Of-Care Health Diagnostics globally.

Job Responsibilities:

• Monitor and evaluate the performance of medical devices.
• Perform testing to generate data for the lot-specific calibration.
• Perform studies to access the accuracy, precision, sensitivity and stability for new products.
• QC for product-related components and biological reagents.
• Compile and analyze data; prepare reports and documentation as required by regulations.
• Assistance for product manufacturing.

Qualifications:

• Minimum BS in Life Sciences or a related science field; Advanced degree is Preferred. Minimum 1 year (including internship) of experience in immunoassays. Preferred Experience in medical device manufacturing, and quality control. Familiarity with relevant regulations and standards such as FDA, ISO 13485, and the Medical Device Directive (MDD) is preferred. Good communication and interpersonal skills, as the role involves working with other team members. Good attention to detail and ability to work accurately and efficiently. Strong analytical, problem-solving and documentation skills