• 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. Smart scopes, 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
• 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.).
How to Apply
For more information please contact below:
Qualified individuals will be contacted for an interview