Quality Lead Inspector

freudenberg; Jeffersonville (IN); On-site; USD 85,000 - 130,000; Full time

Job summary

Freudenberg Medical LLC in Jeffersonville, IN, seeks an experienced Quality Inspector Lead to manage daily inspection activities, mentor inspectors, and ensure adherence to ISO 13485 and FDA 21 CFR Part 820. You will coordinate workload, maintain timecards, and drive continuous quality improvements.

You will work with SAP and MasterControl to ensure data integrity and compliance, while partnering with cross-functional teams to resolve complex quality issues and support production schedules.

Qualifications

• Must have a high school diploma or GED.
• 8+ years in quality-related roles.
• Extensive knowledge of medical device regulations (ISO 13485, FDA 21 CFR Part 820).
• Proven ability to lead teams, drive quality initiatives, and mentor inspectors.

Responsibilities

• Lead daily inspection activities within the Quality department and coordinate inspector workload.
• Maintain QC inspector timecards and approve payroll.
• Approve purchase requests for QC supplies and equipment.
• Train inspectors and ensure standard work is followed.
• Schedule quality inspection activities to support operations.
• Analyze system performance and drive improvements.

Skills

Leadership

Coaching

Communication

Problem solving

Quality systems knowledge

Education

High school diploma or GED

Tools

SAP

MasterControl

Job description

Working at Freudenberg: We will wow your world!

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.

Qualifications

• 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.

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.

Freudenberg Medical LLC