Quality Test Technician III jobs in United States
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Enable Injections, Inc. · 2 hours ago

Quality Test Technician III

Enable Injections, Inc. is seeking a Quality Test Technician III to ensure product safety and regulatory compliance. The role involves executing finished product testing, managing quality documents, and supporting manufacturing operations to maintain high-quality standards.

Health CareLife ScienceManufacturingMedical Device

Responsibilities

Assist with Batch Disposition responsibilities for Materials, Components, and Sub-Assemblies
Ensures product safety, regulatory compliance, and compliance through proper management of quality documents and quality records
Execute finished product testing per defined procedures and work instructions
Produce high-quality records of results, with attention to detail and adherence to Enable Injections quality requirements
Collaborate with colleagues to diagnose and resolve unexpected issues which arise during routine operations
Support Manufacturing Operations through Operator compliance to Quality system, Quality Alerts, Training, In process Audit Inspections, Specialty Quality Inspections, Manufacturing record review, Inspection guidance, etc
Support Quality Department with assisting in data collection for metric reporting, Quality improvement projects, special audits, and development of inspection methods
Support company corporate goals and objectives, infrastructure goals and objectives, manufacturing goals and objectives, and Quality Management System goals and objectives
Report “out of control” conditions and assist operations in analysis and reaction procedure
Support DHR document review for completeness and compliance
Maintain a clean, organized, and safe work environment
Take responsibility for own safety
Hold self-accountable to follow all safety policies & procedures
Support debrief accidents & implement solutions to eliminate root cause

Qualification

Quality Control/AssuranceISO13485 KnowledgeFDA 21 CFR820 KnowledgeSAPMicrosoft OfficeDocumentation PracticesMechanical AptitudeInterpersonal SkillsProblem SolvingTime Management

Required

High School diploma or GED
A minimum of four (4) years of previous industry experience with required, testing, and/or measurement experience
Good working knowledge of product and manufacturing processes within the plant
Attention to detail and experience with good documentation practices

Preferred

Proficient in all aspects of Quality Control/Assurance procedures and possess a detailed knowledge of product components and their impact on assembly and use of the finished product
Knowledgeable of ISO13485 Quality Standard
Knowledge of FDA 21 CFR820 regulations
Experience with testing and documentation in a regulated industry

Company

Enable Injections, Inc.

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Cincinnati-based Enable Injections is a global healthcare innovation company developing and manufacturing drug delivery systems designed to improve the patient experience.

Funding

Current Stage
Growth Stage
Total Funding
$352M
Key Investors
SanofiMagnetar CapitalORI Capital
2026-01-06Corporate Round· $30M
2022-01-27Series C· $215M
2020-09-08Debt Financing· $25M

Leadership Team

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Mike Hooven
President and CEO
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Tim Flaherty
Executive Vice President , Chief Financial Officer
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Company data provided by crunchbase