5 дней назад
Inspector I (Medical Devices)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Inspector I (Medical Devices) (Quality Control/ISO 13485): Inspecting raw materials, subassemblies, in-process products, and finished medical devices with an accent on dimensional, visual, and functional inspection, documentation accuracy, and regulatory compliance. Focus on processing non-conforming materials, reviewing DHRs and sterilization records, supporting quality investigations, and improving inspection methods in a regulated manufacturing environment.
Location: Allen, Texas, USA; onsite
Company
Nordson Medical designs, develops, and manufactures complex medical devices and component technologies for life-saving applications.
What you will do
- Inspect incoming raw materials, subassemblies, in-process products, returned goods, and finished medical devices.
- Perform visual, dimensional, and functional inspections using calipers, micrometers, and vision measurement systems.
- Review inspection data, device history records, sterilization records, and production line clearances for compliance.
- Document and process non-conforming materials and products, and support customer complaint and quality deviation investigations.
- Coordinate with Manufacturing, Engineering, Supply Chain, and internal customers to maintain product quality.
- Support continuous improvement, expiration-date evaluations, LAL testing, sterilization preparation, and 5S activities.
Requirements
- High school diploma or equivalent; an associate degree in a technical field is preferred.
- At least 2 years of experience in quality control, inspection, manufacturing, or a regulated industry.
- Ability to read and interpret engineering drawings, specifications, procedures, and test methods.
- Experience with ERP or eQMS systems such as SAP, Oracle, Q-Pulse, MasterControl, or equivalent.
- Knowledge of Quality System Regulation, ISO 13485, and Good Documentation Practices is preferred.
- Ability to lift up to 50 pounds and use a pallet jack.
Nice to have
- 3–5 years of experience in medical device or FDA-regulated manufacturing.
- Experience with Keyence, OGP, or equivalent vision measurement systems.
- Associate degree in a technical field.
Culture & Benefits
- Collaborative and inclusive work environment.
- Opportunities to build technical skills and advance professionally.
- Work in a growing medical technology organization supporting life-saving products.
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