Quality Lead Inspector

Freudenberg Medical LLC; Jeffersonville (IN); On-site; USD 85,000 - 125,000; Full time

Job summary

Freudenberg Medical LLC is seeking a quality leader to manage daily QA inspection activities, oversee testing of materials, and ensure compliance with ISO 13485 and FDA requirements.

You will mentor inspectors, coordinate with production, and drive system improvements. This on-site role requires the ability to stand, lift up to 50 lbs, and work in a cleanroom environment. Join a global technology group committed to diversity and inclusion.

Qualifications

• High school diploma or equivalent (GED).
• 8+ years in quality-related roles in medical devices.
• 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.

Responsibilities

• Lead and direct 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.
• Oversee the inspection and testing of materials, parts and products to ensure adherence to established requirements and quality standards.
• Oversee non-conforming materials and dispositioning per MRB.
• Tests and controls WIP, raw material and finished product quality, ensuring compliance with company standards and applicable government regulations.
• Analyze and correct issues with system performance, and identify and drive system improvements.

Skills

Leadership

Coaching

Communication

Quality Assurance

Regulatory Awareness

Education

High school diploma or equivalent

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 Welcome to Freudenberg Without Freudenberg, indoor air would not be as clean, cars would not drive and wounds would not heal as quickly. And these are just three examples from thousands of our applications. Working at Freudenberg: "We will wow your world!" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 51,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.