Posted 24 days ago
Quality Technician II
AI Summary
Performs quality testing and inspection tasks in medical device manufacturing, applying QMS procedures, GMP principles, and statistical process control to support CAPA investigations and regulatory compliance.
About this role
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 LLCSkills
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