Qualifications

Associates degree in Engineering, Quality, or a related field
1 years of experience in quality engineering, manufacturing, or a regulated industry preferably medical device preferred
Knowledge of quality standards such as ISO 13485, FDA regulations, or GMP
Experience with root cause analysis, CAPA, and process validation helpful

Benefits

Responsibilities

A key player in ensuring high-quality products that contribute to saving lives
Develop, implement, and maintain quality control processes to ensure compliance with industry standards and regulatory requirements
Conduct root cause analysis and implement corrective and preventive actions (CAPA) to address quality issues
Collaborate with engineering, production, and regulatory teams to enhance product quality and manufacturing efficiency
Perform risk assessments and support validation activities for new and existing processes
Analyze quality data, generate reports, and drive continuous improvement initiatives
Support audits, including internal, customer, and regulatory audits, ensuring compliance and readiness

Job Type: Full-time

Pay: $23.24 - $24.22 per hour

Schedule:

Work Location: In person

Unetixs Vascular, Inc.

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