Quality Engineer I
Visby Medical
Quality Assurance
San Jose, CA, USA
Posted on Apr 16, 2025
About Visby
Visby Medical is an ambitious, well-funded late-stage biotech startup. Driven by a belief that infectious disease diagnosis should be quick, accurate, and accessible to all, Visby has developed the world’s first single-use PCR platform that disrupts the traditional model and redefines the way infectious disease is tested and treated.
The Quality Engineer 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.
How You’ll Make an Impact
- Initiate and chair the non-conforming material board (NCMR) process.
- Provide support to drive CAPA investigations and corrective and preventive action implementations.
- Review and approve Document Change Orders, and Engineering Change Orders.
- Apply Quality Systems knowledge to drive process improvements.
- Apply statistical tools to analyze data and identify root cause and drive problem resolution.
- Work with Operations, 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 regular walk throughs of warehouse and manufacturing areas to ensure GMP compliance.
- Other duties as assigned
On Your First Day We’d Like You to Have
- Bachelor’s Degree in an applied science or engineering field.
- Minimum of 2 years of experience in Quality Assurance in the medical device field.
- Demonstrated a working knowledge of 21 CFR 820, ISO 13485, and other international standards.
- Knowledge and experience with ERP/MRP systems and their applications preferred.
- Excellent written and interpersonal communication skills.
It’s Great If You Have
- Demonstrated ability to address challenges with creative problem-solving techniques.
- Exceptional problem-solving and organizational skills.
- Ability to understand and explain complex quality issues to non-experts.
More about our benefits
Visby offers highly competitive health insurance through Cigna or Kaiser, including a company-funded HSA option. We also offer flexible paid time off, 11 company holidays, and many other contemporary benefits and perks.
Visby is a proud recipient of the 2023 Cigna Healthy Workforce Designation.
Additional information
We believe that the unique contributions of all Visbees is the driver of our success. To make sure that our products and culture continue to incorporate everyone's perspectives and experience we never discriminate on the basis of race, color, religion, creed, national origin, ancestry, sex, gender, pregnancy or related medical conditions, sexual orientation, gender identity or expression, age, disability, medical condition, genetic information, marital status, or military or veteran status.
Full COVID Vaccination Required - Reasonable accommodations for medical or religious reasons considered.