Quality Lead Inspector

About the Role

Freudenberg Medical is a trusted Contract Manufacturing Organization (CDMO) partner, delivering high-quality solutions from ideation and market launch to volume production for medical device and pharmaceutical companies. With proven expertise in materials and technologies, Freudenberg Medical offers an extensive range of vertically integrated capabilities: precision molding and extrusions, complex catheters, hypotubes, and coatings.

You will support our team as a Quality Lead Inspector at our Jeffersonville, IN on-site location.

Responsibilities

• Leads and directs the daily activities of all inspection functions within the Quality department and coordinates inspectors’ workload.
• Maintains QC inspector timecards and approves payroll.
• Places purchase requests for QC operating supplies and office equipment.
• Trains QC inspectors, ensuring standard work is being followed.
• Determines training targets, updates, and maintains the versatility matrix.
• Applies sampling standards and ensures the 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.
• Oversees the inspection and testing of materials, parts, and products to ensure adherence to established requirements and quality standards.
• Provides oversight of non-conforming materials and ensures product is properly segregated and 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.

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.

Benefits

• 401K Match: Save for retirement with the company’s help.
• Diversity & Inclusion: We focus on providing an inclusive environment and recognize our diversity contributes to our success.
• Sustainability & Social Commitment: We support social and sustainable projects and encourage employee involvement.
• Health Insurance: Rely on comprehensive services whenever you need it.
• Personal Development: We offer a variety of trainings to ensure you can develop in your career.

We offer a comprehensive benefits package that includes medical, dental, and vision coverage, retirement savings with company match, and paid time-off. Additional details will be shared during the recruitment process.

Candidates must be legally authorized to work in the United States without current or future visa sponsorship.