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QA Compliance Specialist job in Irving, TX

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Irving, TX CorTech LLC

Job Ref:  350381
Employer:  CorTech LLC
Job Type:  Contract
Salary and Benefits:  28.98/Per Hour
Remote:  No

Location

City:  Irving, TX
Post Code:  75038
Map: 

Description

JobsRUs.com. is seeking to hire a QA Compliance Specialist for our client in Irving, TX!
Benefits Available!
Weekly Pay!
$28.98/Hour
Start Time (AM/PM)
8:00 AM
End Time (AM/PM)
5:00 PM

The QA Compliance Specialist position exists to support the execution of quality & regulatory functions in the organization to ensure compliance of the AV-SH quality/business systems to applicable regulations, standards and corporate policies. Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Support external audit activities (FDA, FDB, ISO registrar audits etc.).
Audit areas of Client Vascular Quality System.
Support administration of Quality System processes (CAPAs, Internal Audits etc.).
Generate and distribute periodic open CAPA and Internal Audit Corrective Action (IACA) reports.
Track and trend compliance activities on a periodic basis. This may include CAPA & IACA metrics etc. Generate compliance metrics for Management Reviews.
Assist the organization to receive timely feedback on open corrective actions.
Participate in cross divisional activities to integrate quality system information.
Conduct review and update Quality System procedures as necessary.
Assist in developing & conducting Quality System training as necessary.
File Quality Records (audit reports, IACAs, CAPAs etc.).
Ensure that all responsibilities are carried out in compliance with governing regulations and standards. Other duties as assigned. Bachelor Degree or equivalent plus 4 + years of related work experience or equivalent combination.

Previous CAPA experience
Prior work in a regulated industry, ideally within quality assurance
Technical writing
Project management
Effective communication skills

Preferred Edu - Bachelor?s degree in Life Science, Engineering, or closely related discipline.

At least 3 years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.
Demonstrates understanding of how their function supports the business. Demonstrates technical and business competencies that drive results and continuous improvement.
ref: (350381)
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