10 дней назад
Quality Technician II (Medical Devices)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Technician II (Medical Devices): Performing product testing, inspections, quality system procedures, and audits in medical device manufacturing with an accent on GMP, statistical process control, and risk management. Focus on CAPA investigations, corrective and preventive actions, ISO 14971 documentation, and learning FDA and ISO 13485 requirements.
Location: Jeffersonville, Indiana, United States; onsite
Company
manufactures medical devices and operates within regulated quality and manufacturing environments.
What you will do
- Apply quality management system procedures in daily work and audits.
- Perform product testing and inspection activities using established methodologies.
- Troubleshoot basic issues, manage consumables, and maintain the work area.
- Use statistical methods, process control, and quality tools such as Six Sigma, DOE, and FMEA.
- Participate in CAPA investigations and implement corrective and preventive actions.
- Apply risk management documentation, including ISO 14971, to support risk mitigation and change management.
Requirements
- High school diploma or equivalent.
- Approximately 3 or more years of relevant experience.
- Intermediate understanding of procedures and the ability to work with moderate guidance.
- Working knowledge of GMP principles in medical device manufacturing.
- Experience with QMS procedures, product testing, inspections, statistical methods, and quality tools.
- Ability to learn FDA regulations, including 21 CFR Part 820, and ISO 13485 standards.
Culture & Benefits
- Full-time employment.
- Equal opportunity workplace committed to diversity and inclusion.
- Work alongside peers and share technical knowledge.
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