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Quality Assurance AssociateVein360 • Blue Ash, Ohio, United States
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Quality Assurance Associate

Vein360
  • US
    Blue Ash, Ohio, United States
  • US
    Blue Ash, Ohio, United States
Jetzt Bewerben

Über

Quality Technician works under the supervision of the Quality Management Representative or their designee and is responsible for ensuring compliance to the requirements of the corporate Quality System and 21 CFR Party 820 (Quality System Regulation). Quality Technician applies relevant experience, knowledge and skill sets to review and approve the output of daily operations (device history records), release raw materials to production, actively drive and support the management of process improvement activities such as Corrective & Preventive Action (CAPA). The Quality Technician is to become an expert in each phase of reprocessing operations and able to provide meaningful input to operations leadership and quality assurance for the continuous improvement of these operations.
Essential Functions
Works within a production, lab and office environment to ensure the safe, compliant and reliable execution of reprocessing operations which include:
Receiving used healthcare products
Incoming inspection and release of raw materials
Cleaning
Drying
Inspection & testing
Packaging & labeling
Sterilization load preparation
Device history record review
Supports critical to quality programs such as:
Process validation
Internal audits
CAPA
Strictly adhere to all corporate environmental health and safety programs including bloodborne pathogens and hazard communication.
Faithfully execute duties against the corporate Quality System.
Use measurement systems and analysis tools to support process improvement/validation activities or establish root cause of non-conformances.
Identify opportunities for improvement and provide feedback to operations and quality leadership.
Support quality system initiatives as assigned.
Comply with applicable FDA requirements and all associated standards / guidance
Education Minimum: Associates degree
Preferred: Bachelor's in science
Experience
1+ years of quality technician or relevant experience within FDA regulated medical device operation
Preferred Skills/Qualifications:
Working knowledge of various pieces of test and measuring equipment including: Micrometers, calipers, digital force gages, motorized test stands, rulers, digital multimeters, laser diode counters, etc.
Familiar with critical manufacturing processes such as packaging and terminal sterilization, including monitoring of controlled environments.
Skills/Competencies
Time management
Root cause analysis
Functional knowledge of Microsoft Office (Word and Excel)
Technical writing
Basic data aggregation and analysis capabilities (e.g., summary statistics)
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  • Blue Ash, Ohio, United States

Sprachkenntnisse

  • English
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