Quality Lead Inspector

Freudenberg Medical; Jeffersonville (IN); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

401K Match

Diversity & Inclusion

Sustainability & Social Commitment

Health Insurance

Personal Development

Job summary

Freudenberg Medical, a leading medical device CDMO, is seeking a Quality Lead Inspector for its Jeffersonville, IN site. This On-Site role leads the daily QC inspection activities and coordinates the inspector workload to ensure compliance with ISO 13485 and FDA 21 CFR Part 820.

You will train inspectors, maintain accurate timecards, and drive process improvements while ensuring materials and finished products meet all quality requirements.

Qualifications

• High school diploma or GED required.
• 8+ years in quality-related roles preferred.
• Knowledge of medical device regulations (ISO 13485, FDA 21 CFR Part 820).
• Experience leading teams, driving quality initiatives, and mentoring inspectors.

Responsibilities

• Lead daily inspection activities within the Quality department and coordinate inspectors.
• Maintain QC timecards and approve payroll.
• Order QC supplies and train inspectors on standard work.
• Oversee testing of materials and products to meet quality standards.
• Schedule inspection activities to support production schedules and resolve issues.
• Identify system improvements and drive corrective actions.

Skills

Leadership

Coaching

Communication

SAP

MasterControl

Quality systems

Regulatory compliance

Education

High school diploma or GED

Tools

SAP

MasterControl

Job description

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 52,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.

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.

Some of your 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.
• *Candidates must be legally authorized to work in the United States without current or future visa sponsorship

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.

Jeffersonville, IN

On-Site

Freudenberg Medical LLC

You support our team as

Quality Lead Inspector

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.