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 least8 yearsin quality-related roles.
Comprehensive knowledge ofmedical device regulationsandquality 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 withSAPandMasterControlsystems 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
Numbers & Facts
Location
Jeffersonville, Indiana
Industry
Medical Devices and Supplies
Company Size
10,000 employees or more
Website
https://www.freudenberg.com/careers
About Company
Freudenberg – ein globales Technologieunternehmen mit rund 48.000 Mitarbeitenden in rund 60 Ländern und einem Umsatz von mehr als 8,8 Milliarden Euro im Jahr 2020. Hauptsitz der Unternehmensgruppe ist Weinheim, inmitten der Metropolregion Rhein-Neckar. Soweit die Zahlen und Fakten. Doch was treibt uns an?
Es ist der Exzellenzanspruch, mit dem wir unsere Kunden voranbringen. Die Branchenvielfalt, die immer neue Anwendungen ermöglicht. Die Innovationskraft, die auf unserer langjährigen Material-, System- und Technologiekompetenz basiert und von vielfältigen Teams inspiriert wird. Die Werte, die uns seit rund 170 Jahren leiten. Und der feste Wille, Verantwortung für Umwelt und Gesellschaft zu übernehmen.
All das macht uns aus.
Skills
Cleanroomunmatched
Coachingunmatched
Code of Federal Regulationsunmatched
Communication Skillsunmatched
Corporate Complianceunmatched
Corrective Actionunmatched
Data Qualityunmatched
Diversityunmatched
FDA (Food and Drug Administration)unmatched
Government Regulationsunmatched
ISO (International Organization for Standardization)unmatched
Leadershipunmatched
Lift/Move 50 Poundsunmatched
Maintain Complianceunmatched
Materials Testingunmatched
Mentoringunmatched
Office Equipmentunmatched
Operational Supportunmatched
Preventative Maintenanceunmatched
Problem Solving Skillsunmatched
Process Improvementunmatched
Quality Assuranceunmatched
Quality Controlunmatched
Quality Metricsunmatched
Regulatory Complianceunmatched
Team Lead/Managerunmatched
Test & Measurement Equipmentunmatched
Time Managementunmatched
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