Sr. Quality Systems Specialist
REQUIREMENTS:
Masters’ degree in Biomedical or Mechanical Engineering and one (1) year experience with quality engineering and one (1) year of post-bachelor’s progressive experience in all of the following: In a quality assurance or quality control environment within a medical device regulated field; Continuous improvement projects through use of tools to include Lean, Six Sigma and Kaizen; FDA requirements for Corrective and Preventive Action (CAPA) Process; Statistical analysis using statistical tools including Excel and Minitab; Problem solving methodologies and root cause analysis; FDA Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), JPAL and ISO 13485, ISO 14971 and ISO 17025; Developing and tracking CAPA process metric to support improvement activities.
