Posted 3d ago

PD Quality Technician II

@ Freudenberg Group
Jeffersonville, Indiana, United States
OnsiteFull Time
Responsibilities:Troubleshoots issues, Manages consumables, Performs inspections
Requirements Summary:Approximately 3+ years relevant experience; high school diploma; GMP/QMS familiarity; associate degree or certification preferred.
Technical Tools Mentioned:GMP, QMS, ISO 13485, Six Sigma, DOE, FMEA, CAPA, ISO 14971, Risk management, FDA 21 CFR 820
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Job Description

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.

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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