Quality Lead Inspector - Medical Device Compliance

Freudenberg Group; Jeffersonville (KY); On-site; USD 70,000 - 90,000; Full time

Job summary

Freudenberg Group in the United States is seeking a Quality Leader to supervise the inspection functions within the Quality department. You will coordinate inspector workload, approve payroll, and manage QC purchasing and training to ensure standard work is followed.

The role requires strong leadership, extensive experience in medical device quality systems, and proficiency with SAP and MasterControl to maintain data integrity and regulatory compliance. Cleanroom work and physical demands apply.

Qualifications

• High school diploma or GED.
• At least 8 years in quality-related roles.
• Knowledge of medical device regulations and quality systems (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, 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.

Skills

Leadership

Quality management

Coaching

Communication

Regulatory knowledge

Education

High school diploma (GED)

Tools

SAP

MasterControl

Job description

Freudenberg Group in the United States is seeking a Quality Leader to supervise the inspection functions within the Quality department. You will coordinate inspector workload, approve payroll, and manage QC purchasing and training to ensure standard work is followed.

The role requires strong leadership, extensive experience in medical device quality systems, and proficiency with SAP and MasterControl to maintain data integrity and regulatory compliance. Cleanroom work and physical demands apply.