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Quality Engineer II at Agiliti - ApplyBlast

Quality Engineer II

Agiliti

4 months ago

3.3 on Glassdoor

Kansas

Hybrid

Full Time

Senior

0 applicants

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About this role

The Quality Engineer II supports quality decisions and practices across Agiliti's manufacturing and design centers, ensuring compliance with internal and regulatory requirements. The role involves applying statistical methodologies, developing testing plans, and collaborating with Design, Manufacturing, and Supply Chain teams to manage supplier adequacy and product specifications. Key activities include leading risk management, process FMEA, quality control plans, and overseeing design verification and validation protocols for medical devices.

Responsibilities

Apply statistical methodologies to resolve product and quality system issues
Develop and maintain testing plans for raw materials and finished goods
Lead risk management and process FMEA activities for medical device manufacturing
Oversee execution of design verification and validation protocols
Coordinate first article inspections and tooling verification validations

Skills

Qualifications

BS in EngineeringISO 13485 certificationFDA 21 CFR 820 knowledgeMDSAP compliance experienceIEC 60601-1 Safety knowledge

About Agiliti

agilitihealth.com

Headquarters

Eden Prairie, Minnesota, United States

Company Size

5001-10000 employees

Founded

1939

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Agiliti is a medical equipment company that helps healthcare organizations access, manage, and maintain essential medical and surgical equipment for optimal patient outcomes. The company offers a broad range of services including medical device rental, onsite equipment management, clinical engineering, surgical equipment repair, and surgical laser and technician services. Agiliti serves more than 10,000 U.S. acute care facilities and also provides specialized solutions for government agencies and medical device manufacturers.