Job Title : Quality Assurance Associate II
Summary : Looking for an opportunity to work on ground-breaking technologies? For over 50 years, my client has been creating an extensive portfolio of reagents, instruments, and service support including diagnostics and clinical applications. As a global manufacturer, each site focuses on a specific area. The site in San Jose, CA focuses mainly on R&D and quality assurance. The portfolio supports a variety of therapeutics including CAR-T, cell and gene therapy, infectious disease research, stem cell research and genetic screening. My client is seeking someone who is seeking to become part of an organization that enhances the technologies of tomorrow.
The Quality Assurance Associate II will be responsible for :
- Ensuring product and process conformance to quality system requirements and ISO13485.
- Participating in projects related to product quality, site compliance, validations, audits (internal and supplier) and CAPA system coordination.
- Writing procedures as needed, managing document changes and change control system/processes.
- Generating Safety Data Sheets for all products with periodic reviews and updates.
The Quality Assurance Associate II should have the following requirements :
- Bachelor's Degree in a Life Sciences or engineering discipline.
- At least 3 years of experience with ISO9001/ISO13485 regulations and in a life sciences or medical device/IVD company.
- Experience working with ISO9001/13485 and Quality System Requirements.
- Ability to work independently and prepare written information concisely.
- Excellent attention to detail, organization and prioritization skills.
If this sounds like something you would be interested in, please apply!
