Sr. Quality Engineer - Diagnostics
Engineering | San Diego, CA | Full Time
We are looking for a Senior level Quality Engineer to work as a quality specialist for real-time medical diagnostics design, development, and manufacture. The right person for this role will be able to develop and implement QMS (Quality Management Systems), as well as to develop processes and procedures in order to ensure compliance, mitigate risks, optimize quality, and improve performance.
This QE will manage deviation and non-conformance investigations, develop corrective and preventative actions, and own CAPAs, NCRs, FMEAs, development and revisions of appropriate SOPs, etc. He or she will also ensure adherence to the cGMP processes for our organization.
This role will interact directly with engineering, manufacturing, sales, facilities, validation, suppliers, vendors, regulatory bodies, and other departments and entities.
Our ideal candidate will have a Bachelor’s degree in a scientific field, or engineering and 7+ years of experience. The Sr. QE should be comfortable working in a regulated environment and have proven experience with FMEAs, CAPAs, and other improvement initiatives.
This is a super visible role and you will be noticed.
This position can work remotely 50% of the time.