San Jose based Visby Medical is an ambitious, well-funded, and fast-paced early stage biotech startup. Driven by a belief that disease diagnosis should be quick, accurate, and accessible to all, Visby is developing a novel diagnostic device platform that aims to redefine the way an infectious disease is tested and treated.
We are developing a tenacious team with deep industry expertise of researchers, biologists, designers, and engineers that is back-stopped by world class operations and administrative resources. If you enjoy tackling challenging problems, are passionate about your work product, and want to join a collaborative ownership team that is aiming to leave a lasting positive legacy in the healthcare industry, please consider the following Associate Quality Engineer opportunity.
This Associate Quality Engineer role will provide hands-on support to Visby's manufacturing environment. This includes having responsibility for the quality of all product and process aspects of the assembly line and ensuring compliance to Visby's Quality System and all applicable regulatory requirements. The ideal candidate has electro-mechanical technical experience and a demonstrated ability to address challenges with creative problem-solving techniques.
- Initiate and chair the non-conforming material board (NCMR) process
- Maintain the equipment calibration process
- Apply Quality Systems knowledge to execute project assignments
- Apply statistical tools to analyze data and identify root cause and drive problem resolution
- Identify and routinely execute the most effective, cost-efficient processes; continually evaluate their effectiveness and appropriateness
- Assist and participate in internal and external audits, including supplier audits
- Produce technical reports to support quality assurance investigations
- Perform other quality-related duties as assigned
- Maintain a safe, organized, and clean work environment.
Education and/or Experience
- Bachelor's Degree in an applied science or engineering field
- Minimum of 3 years of experience in Quality Assurance of class II or III with embedded software in the medical device field
- Demonstrated competency with 21 CFR 820, ISO 13485, ISO 14971, and other international standards
- Exceptional problem-solving and organizational skills
- Ability to understand and explain complex quality issues to non-experts
- Knowledge and experience with ERP/MRP systems and their applications preferred
- Must have in-vitro diagnostics or medical device experience.
- Excellent written and interpersonal communication skills.
- Comfortable performing repetitive tasks and/or motions.
- Must be able to lift a minimum of 10 lbs.