Quality Control Inspection Lead

Job Title: Receiving Inspection Lead

Location: San Diego, CA

Contract Term: 6+ Months

1st Shift

Description:

Position Is For Receiving Inspection Lead

The Receiving Inspection lead is responsible for assisting the manager with a team of up to 10 Inspectors and for all aspects of inspection-associated record keeping. actively finding ways to improve productivity, maintaining test equipment, and compliance with all quality requirements and procedures.
• May assist with train inspectors in incoming inspection, cable in process and final inspection.
• Work with operations to set priorities for inspection activities.
• Ensure that necessary record keeping is completed in a timely manner and appropriately stored.
• Assure that equipment is maintained and in calibration.
• Ensure that material is clearly identified as to inspection status, defective material documented
• Work closely with Quality Engineers, Manufacturing Engineers, and Prod Development/Design Engineers to resolve issues.
• Knowledge and experience of the operation and utilization of Coordinate Measurement Machines (CMMs) and similar measurement equipment. (e.g. Smartscopes, Keyence IM systems, Zeiss CT scanners, etc.)
• Experience with enterprise software; SAP experience strongly desired.
• Advise others on methods for resolving measurement problems using their experience of GD&T, inspection, and measurement equipment.
• Assist with audit preparations and new product launches.
• Assist in providing leadership and training to the Receiving Inspection team.
• Assure compliance to the Quality Management System (QMS).
• Assist in the maintenance of the Quality Management System related to quality processes.
• Knowledgeable of current ISO standards and Federal Regulations (GMP)
• Participate in reviewing and improving the quality system.
• Oversee and assure the appearance of the QC lab through 5S methods
• Assist in the planning, directing and controlling operations of the QA Dept. to assure very high quality of goods.
• Perform other duties as assigned
• Assist in activities regarding the disposition of non-conforming materials through Quality Notifications (QN); such as generating, routing, recording and the usage decision into SAP.
• Experience in medical devices

Qualifications
• AA degree Bachelor degree strongly preferred in relevant field.
• Minimum of 5-7 years of experience in Supervision of Quality Control inspection operation required
• 5+ years of Metrology experience is strongly desired
• Experience with CMMs (OGP SmartScopes, Keyence IM systems, Zeiss CT Scanner, etc.).
• Experienced in developing fixtures associated with automated inspection.
• Ability to read blueprints and drawings; GD&T knowledge is required.
• Professional knowledge of standard inspection and test equipment (e.g., calipers, micrometers, pin gages, CMMs).
• Professional knowledge of statistical sampling plans (e.g., C=0, ANSI Z1.4).
• Medical Device, Injection Molded components, and Circuit Board inspection experience is preferred.
• Basic understanding of Microsoft Office applications.
• Technical interface software knowledge such as SolidWorks is a beneficial.
• ASQ certification and/or Six Sigma Lean Manufacturing certification is a plus.

Providing assistance to assure documentation and procedures are followed, updated and maintained as required by internal Quality Policies and related FDA/GMP guidelines. Must demonstrate a working understanding of the pertinent Quality Systems Regulations (i.e.: Good Manufacturing Practices, ISO, FDA). Proven ability to develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance. Capable of using Microsoft programs and ability to learn other systems. Working knowledge of statistical methods as well as statistical application software. Effective verbal and written communication skills. The ability to work in teams and independently with minimal supervision to obtain results as required. Must be self-motivated/directed, organized, detail oriented and have ability to multi-task projects. Professional certification is an advantage (i.e. CQA, CQE, SQE, CQM, Six Sigma, etc.).