Lead Quality Inspector - Medical Devices

Summary

Perform and monitor inspection and quality control activities and provide related on-the-job training to support the manufacturing group's on-time delivery and quality objectives and adhere to the Quality Management System, all applicable government regulations, and customer requirements.

Essential Duties and Responsibilities

• Establish and perform first article (FAI) activities for effective design transfer, utilizing basic and advanced measurement equipment and ensuring the manufactured products are traceable to documented standards.
• Audit the production jobs by conducting in-process inspections on the floor and reviewing related documentation. Provide on-the-job training and coaching to improve mechanical inspection competency as well as compliance to inspection frequencies, process controls and Good Documentation Practices (GDP).
• Troubleshoot mechanical and/or programming issues with the company's measuring equipment and related software.
• Ensure the group's gages are in good condition, accurately maintained in the GageTrak database and calibrated at the required intervals according to NIST standards. Procure gages as required. Train production associates on the use of GageTrak.
• Support engineering and management with the root cause analysis of customer rejections and internal quality failures, and participate in the implementation of corrective action and/or provide training as needed.
• Perform and accurately document 1st piece, in process and final inspections to support the group as needed.
• Sustain housekeeping and 5S efforts in the Inspection areas as well as perform preventive maintenance on the measuring equipment, such as the Comparator and CMM and others.
• Actively participate on the Quality Control team, recommending, developing and implementing process improvements, standardization, and related documentation.
• Understand and comply with company policies, safety guidelines, quality system procedures and housekeeping standards.
• Performs other miscellaneous job duties and related functions as needed.

Supervisory Responsibilities

This job has no supervisory responsibilities.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience

High school diploma or equivalent and a minimum of 5-7 years of related experience and/or training in mechanical and visual inspection preferably within a regulated industry.

• PC Navigation and MS Word experience
• Capable of reading and interpreting blueprints
• Experience in using standard measuring tools and equipment (e.g. calipers, micrometers, probes, CMM, Comparator)
• Demonstrated knowledge of Geometric Dimensioning & Tolerancing (GD&T)
• Accurate, detail-oriented, and organized
• Good verbal and written communications skills
• Reliable