Current Job Openings
Department: Quality / Document Services
Job Title: Quality Control Inspector
Location: Menlo Park, CA
Job Summary:
A Quality Control Inspector is responsible for in process and final inspection of finished devices and subassemblies. In addition, other Quality Assurance related tasks will be assigned such as participation in internal audits of the production line, LHR review, labeling inspection and in process destructive testing such as the liner adhesion testing for the Guide Catheters. The QC Inspector will coordinate the MRB activities and assure proper segregation of the rejected devices from the inspected lot, prior the lot is closed and transferred to the next process step. In addition, the QC Inspector will participate in the inspection process of R&D and validation builds.
Duties & Responsibilities:
- Perform visual inspection of finished products or subassemblies to assess compliance to inspection documents and other specifications;
- Document inspection results, organize and maintain inspection records;
- Interface with engineers to explain and address non-conformities.
- Provide feed-back to Quality Engineers to refine inspection criteria and to improve inspection tools. Assist in creating Inspection Instructions.
- Audit production processes and practices to ensure compliance to GMP requirements;
- Review paperwork for accuracy and completion, by assuring that the NCMRs are properly closed with the necessary approval and reconciliation of the lot, that the referenced deviations and other forms such as the liner adhesion test results are completed and attached as well.
Qualifications:
- Previous experience (3-4 years) of QC Inspection
- Familiarity with common inspection tools (calipers, micrometers, pin gages, video systems etc) and cleanroom environment
- Able to read and follow inspection documents
- Good knowledge of GMP
- Ability to work under pressure in a dynamic, fast-paced environment
- Ability to multi-task and interact well with others
- Basic knowledge of Word and Excel.
