QA Specialist

Job Function:    

• Primary job focus is to ensure that the company is adhering to its Quality Policy. Provides Quality Assurance support to development projects from the Concept Phase through the Market Release Phase. Most important responsibility is ensuring that product used for human use has undergone the requisite quality control checks. The Quality Assurance Specialist receives direct supervision from the Quality Manager, but shall be relatively autonomous and proactive in addressing their project responsibilities. As required, the Quality Assurance Specialist shall elicit guidance from Senior Staff (RA, CTO, Operations, and CEO) and members of the project teams. Responsibilities include:

Description:  

• Ensure lot release testing is adequately performed.
• Support Management Representative and Management Reviews.
• Support audits of Avantec Vascular by outside agencies; ensure that all observations or nonconformance’s are properly rectified. 
• Ensure that product sterilization is adequately controlled and validated.
• Manage continuing cleanroom validations.
• Support setup and management of Design History Files and Technical Files for all projects as required.
• Support Design Verification, Qualification, and Validation Testing Plans.
• Support R&D activities – including but not limited to: in-house testing and test method development, testing performed by vendors.
• Support development and review of Quality Plans.
• Assist in preparation of regulatory submissions.
• Support sterilization validation, biocompatibility testing, packaging validation, etc. required for the submission package.
• Perform supplier audits and ensure that suppliers are approved.
• Provide engineering and technician support in appropriate product, process or component testing.
• Support the Product Complaint process.
• Support the Equipment system.
• Participate in FMEA analyses and other risk management related activities.
• Support Regulatory Affairs to set In-vitro and In-vivo data requirements for submissions.
• Supports the Avantec Vascular Quality Policy and Quality System.
• Performs other duties and projects as requested.

Training and Experience Required:  

• Under certain circumstances, and at Management's discretion, specific training and/or experience may fulfill the requirements of this position.
• 1 yr. experience and coursework related to Quality Assurance.
• Familiar with FDA Quality System Regulation, GMP Guidelines, Medical Device Directive, and IS013485.
• Must have technical, hands-on background with capabilities of proactively addressing and solving issues rather than solely identifying issues.

Education:

• Minimum of Bachelor's degree in Biomedical, Mechanical, or Biomedical Science or related degree.