26 Technology Drive Irvine, CA 92618 US
General Description and Duties:
- Quality Systems: Works as part of the Operations and Quality Department, troubleshoots and analyzes problems to identify, evaluate, propose, and implement corrective actions while documenting the process and verifying the results. Ensures that product documentation is in accordance with Quality System requirements.
- Production: Contributes to the development and implementation of inspection fixtures, measurement systems, and facilitates calibration and preventive maintenance (PM) of such, as applicable. Works with all internal customers and external service vendors to schedule service dates and consolidate equipment into staging areas and then distribute back out to points of use. Acquires vendor quotes for items being serviced. Collaborates with Engineering and Quality to resolve equipment related non-conformances (e.g., out of tolerance conditions, missing, lost, or damaged equipment).
- Documentation: Reviews assigned controlled documents (e.g., work instruction, quality specifications, engineering specifications, calibration records / reports) and might suggest edits to improve compliance and/or efficiency of processes.
- Safety: Performs job functions in a safe and effective manner. Helps promote employee adherence to safe procedures and practices throughout the company.
- Logs & Recordkeeping: Maintains compliance of quality related logs and records, including but not limited to, TE Items List, CAL/PM, Training, and others as assigned.
- Knowledge and exposure to equipment qualification, testing, calibration, and maintenance.
- Experience in a fast paced, multitasking environment with the ability to organize and prioritize multiple tasks and meet deadlines.
- Associate degree, Technical Certificate, or equivalent work experience in medical device industry or similar regulated industry.
- 3 years of experience in medical devices, operations, or quality including usage, calibration, and PM of complex electromechanical equipment and fixtures.
- Experience working under regulated quality systems such as cGMP’s, ISO, and the MDD / AIMDD / MDR is a plus.
- Familiarity with Design Control procedures and requirements is a plus.
- Experience with Class II or III devices is a plus.
Meet Your Recruiter
Erika Castro is a recent graduate from Chapman University, where she majored in Sociology and minored in Latinx and Latin American Studies. As a Recruiter at Marquee Staffing, she specializes in manufacturing and production roles within the medical device industry. Her previous recruiting experience involved working for the state of California to fill open seasonal positions.
In her free time, Erika enjoys hiking the nearby hills, traveling to San Francisco and Mexico, and reading the newest book that has caught her interest.