PD Quality Technician II

Freudenberg

Jeffersonville, Indiana

JOB DETAILS
SKILLS
Change Management, Code of Federal Regulations, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Diversity, Documentation, FDA Requirements, Failure Mode and Effects Analysis (FMEA), GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Manufacturing, Medical Equipment, Medical Protocols, Product Testing, Quality Assurance Methodology, Quality Control, Risk Management, Six Sigma, Statistical Process Control, United States Department of Energy (DOE)
LOCATION
Jeffersonville, Indiana
POSTED
30+ days ago

Working at Freudenberg: We will wow your world!

Responsibilities:

  • Intermediate understanding of procedures.

  • Troubleshoots basic issues.

  • Manages consumables and work area.

  • Shares knowledge with peers.

  • Receives a moderate level of guidance and direction.

  • Experience applying QMS procedures in daily tasks and audits.

  • Working knowledge of GMP principles in medical device manufacturing.

  • Proficient in product testing and inspection methodologies.

  • Practical use of statistical methods, process control, and quality tools (e.g., Six Sigma, DOE, FMEA).

  • Experience using risk management documentation (e.g., ISO 14971) for risk mitigation and change management.

  • Active participation in CAPA investigations and implementation of corrective/preventive actions.

  • Learning FDA regulations (21 CFR Part 820) and ISO 13485 standards.

Qualifications:

  • High school diploma or equivalent.

  • Certification or associate’s degree preferred.

  •  ~3+ years relevant experience.

‎ ‎

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

About the Company

F

Freudenberg

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.
COMPANY SIZE
10,000 employees or more
INDUSTRY
Medical Devices and Supplies
WEBSITE
https://www.freudenberg.com/careers