PTS Advance is seeking to hire a Senior Quality Systems Engineer to join one of our medical device clients who is a recognized leader in the design, development, and manufacturing of advanced drug delivery devices. This position is fully onsite at my client's fantastic facility in Charleston, South Carolina.

As the Senior Quality Systems Engineer, you will establish and support a work environment of continuous improvement that supports the company's Quality Policy, Quality System, and the appropriate regulations at the South Carolina site. Must have a strong background in ISO 13485:2016 / MDSAP regulatory requirements (including FDA QSR, European MDD/MDR,) is required. Responsibilities include:

Main Responsibilities

• Maintain Site training compliance
• Provide Quality related training
• Organize Site Management Review
• Track and report KPIs
• Supplier qualification including leading audits
• Plan, coordinate, and conduct scheduled internal audits to assess compliance with FDA, ISO, other applicable standard requirements, and internal requirements. 
• Manage and/or support audit front room and backroom activities during external audits
• Responsible for conducting, and confirming follow-up actions on Corporate Audits
• Attend global conference calls and meetings related to the site quality management system.
• Drives change in procedures and standards to facilitate work efficiency and maintain quality
• Responsible for the implementation, coordination, and continuous review of the CAPA system
• Facilitation of CAPA management in other areas of the organization
• Perform Document Control tasks within Team Center
• Create and process change notices
• Perform additional tasks as needed for the support of Production systems (MES, SAP)

Required Qualifications

• Bachelor's degree in Life Science or equivalent
• Minimum of 5 years experience in Quality Assurance or medical device field
• Record of success and broad understanding of contemporary quality practices as they apply to product development, manufacturing, and commercial operations
• Experience in GMP and other Regulatory compliance requirements

If you or someone you know may be interested, please send your resume to Lisa.Oster@PTSadvance.com or visit us at jobs.PTSadvance.com to learn more about the role. #LifeSciences #PTSAdvancejobs #PTSAdvance