Inspector 1, Quality Control
Interview: In person/Phone
Job Duration: 12+ Months
Job Location: San Diego, CA 92121
· The Quality Control Inspector is a team member of the Operations Quality Team with the responsibility of making sure that manufactured products meet a set of predetermined quality standards.
· They separate out any products that fail inspection and make recommendations on how to improve the production process in order to reduce the product inspection failure rate.
· Support production order/manufacturing line inspections, equipment calibration, PM, and other line clearance requirements.
· Review and visually inspect materials staged for production or release and ensure the correct material and batches are staged.
· Coordinate and/or performs the segregation and handling of rejected lots until their final disposal.
· Support label printing process, by performing label inspections and content verification.
· Review manufacturing process for compliance with established work instructions (adherence to in-process controls and material storage).
· Verify that the correct material and quantity was allocated for release and archived packets
· Support medical necessity review and release of products and archived packets
· Verify label reconciliation and post-production line clearance.
· Document and investigate manufacturing non-conformities. Contain non-conforming product and assist with implementation of deviations and rework as required.
· May include other duties as defined by the department Manager.
· Works within and across functions for assigned Quality systems
· Typically requires a minimum of a bachelor’s degree
· Minimum of 4-6 years working within FDA/ISO regulated industry
· Accurate and timely data evaluation skills and attention to detail
· Team oriented with excellent communication skills
· Proficiency with Microsoft Office tools (Excel, Word, and PowerPoint)
· Ability to apply medical device quality system requirements (21 CFR 820, ISO 13485, etc.) to manufacturing processes and documentation
· Consistent application of Quality system standards to assigned Quality system area.
· Strong presentation skills
· Experience in Document Control preferred
· Should possess strong interpersonal and coordination skills