The Catalyst Recruiting Group www.catgroupinc.com has been tasked to help grow a Quality Engineering department for a medical products client located outside of Orlando, Florida. This position works directly with Manufacturing, Engineering and R&D to implement the highest level of quality assurance for the design, testing, and release of materials, components and completed products as required by FDA regulations and ISO 13485, MDD and CMDR. This role is also focused on continuous improvement of product and process and will provide engineering input for corrective and preventative action. Also key for this role are internal audits, supplier audits, CAPA system, environmental monitoring, and OEM customer support

REQUIRED: Bachelor’s degree Engineering preferred. 6+ years in an FDA regulated industry in a Quality Assurance function.  Supervisory experience preferred. Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) credential desired. Six Sigma or Lean training desired. Project management, statistical process control, design of experiments, failure mode and effects analysis and process validation. FDA Quality Systems Regulations and have prior experience in FDA regulated industry, preferably medical devices.

They offer an attractive base salary ($75-85k ), annual bonuses, outstanding benefits, and relocation assistance as well as unlimited growth potential.

Greg Giltner
greg@catgroupinc.com
803-223-9126
320-205-2266 (fax)
www.linkedin.com/in/giltner