Quality Assurance Associate

Job Description

Job Description

Salary:

Quality Assurance Associate 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 Assurance Associate 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 Assurance Associate 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.

This position is 100% on-site. Must be able to commute to Blue Ash, OH.

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)