Quality Lead Inspector

Freudenberg•Jeffersonville, IN

6d•Onsite

About The Position

This role leads and directs the daily activities of all inspection functions within the Quality department and coordinates inspector workload. The position involves maintaining QC inspector timecards, approving payroll, and placing purchase requests for QC operating supplies and office equipment. A key aspect is training QC inspectors, ensuring standard work is followed, determining training targets, and updating the versatility matrix. The role also involves applying sampling standards and ensuring the team is cross-trained. Operational checks, preventative maintenance, and accuracy verifications of measurement and test equipment are performed. The Quality Lead Inspector oversees the inspection and testing of materials, parts, and products to ensure adherence to requirements and quality standards, including the management of non-conforming materials and proper segregation/disposition. They test and control WIP, raw material, and finished product quality, ensuring compliance with company standards and government regulations. The role is responsible for interpreting and executing inspection requirements, scheduling quality inspection activities to support operations, and analyzing/correcting system performance issues while driving improvements.

Requirements

High school diploma or equivalent (GED).
At least 8 years in quality-related roles.
Comprehensive knowledge of medical device regulations and quality systems (e.g., ISO 13485, FDA 21 CFR Part 820).
Proven ability to lead teams, drive quality initiatives, and mentor inspectors on procedures, standards, and tools.
Strong leadership, coaching, and communication skills; ability to anticipate quality risks and implement preventive actions.
Experience with SAP and MasterControl systems to ensure data integrity and compliance.
Ability to stand for long periods, perform fine motor tasks, lift up to 50 lbs., and work in cleanroom environments.

Responsibilities

Leads and directs the daily activities of all inspection functions within the Quality department.
Coordinate inspector’s workload.
Maintain QC inspector timecards and approve payroll.
Place purchase requests for QC operating supplies and office equipment.
Train QC inspectors making sure standard work is being followed.
Determine training targets, update and maintain versatility matrix.
Applies sampling standards.
Ensures team is cross-trained.
Performs operational checks, preventative maintenance checks and accuracy verifications of measurement and test equipment used in production, Engineering and other areas.
Oversee the inspection and testing of materials, parts and products to ensure adherence to established requirements and quality standards.
Oversight of non-conforming materials and ensuring that product is properly segregated dispositioned per MRB.
Tests and controls WIP, raw material and finished product quality, ensuring compliance with company standards and applicable government regulations.
Interprets and executes inspection requirements according to company requirements.
Responsible for scheduling quality inspection activities to support operations in meeting required schedules or to resolve complex problems.
Analyzes and corrects issues with system performance, and identifies and drives system improvements.