Quality Engineer

Job Summary: Sr Quality Engineer Location - Otay Mesa, San Diego, CA(100% onsite 5 days a week) Duration: 12Months Client: medical Contract W2 Only Job Summary: Sr Quality Engineer is responsible for maintaining the quality assurance support for the picking, relabeling, and repacking of finished goods prior to shipments to external or internal customers. This person will partner with cross function members to ensure product quality and timely product delivery. Functional Responsibilities: 1. Core Quality Assurance Responsibilities a. Review, sign off on batch record, scan, and store daily batch records and line clearance records for reagent R&R process b. Manage and retain records for the R&R verifier qualification program c. Scan, upload, and physically store QMS records (i.e., EMS reports, training records, validation reports, etc.) per document retention policy d. Address issues pertaining to material master data and material manufacturing batch discrepancies e. Manage ABI-OEM material program including quarantining incoming material batches, pulling QC & QA samples, shipping samples to appropriate testing & inspection sites, managing batch paperwork, and releasing product f. Initiate or create material nonconformance report (NCMR) or quality notification (QN) in event of quality issue, be able to support root cause investigation, and support the execution of corrective actions. Manage nonconforming inventory (physically and systemically) g. Manage nonconforming inventory: *Physically quarantine and tag nonconforming materials *Maintain MRB cage material log *Systemically move and block materials in SAP 2. Validation : Execute on equipment IQ/OQ under the guidance and supervision of Staff Quality Engineer or designee. 3. Training – Maintain training compliance for self. Support training of junior teams either within QA or from cross functions. 4. Quality Metrics – Gather quality data, create quality trending chart, and analysis of trending for quality system review and management review. 5. Miscellaneous Responsibilities: *Keeps manager informed of important changes/issues affecting product release or quality issues arising from the Mfg floor. *Follows Environmental, Health and Safety (EH&S) policies and procedures. Takes responsibility for safety in immediate work area. Participates in EH&S programs. Notifies supervisors of all observed hazardous conditions or unsafe work practices. May provide recommendations on maintaining the safety of the work environment. *Supports external customers as well as the following internal customers, such as; Operations, R&D, Production Planning, Quality Engineers, and Logistics *Performs other related duties and assignments as needed. Education: Requires a minimum of a Bachelor’s Degree in science, engineering, or other relevant discipline. A minimum of 7 years relevant experience or a combination of higher education and relevant experience. Knowledge and Skills: Basic knowledge of ISO 9001, ISO 13485, and other applicable regulatory bodies. Limited/Basic application of Quality Systems principles and applicable Regulatory and/or Business requirements Self-driven and detail oriented. Able to work independently and with minimal supervision. kindly share resume at gaurav@stellarconsulting.com or call me at 678-935-7045 to discuss more!

Location: San Diego, CA, US

Posted Date: 6/26/2025