Experience/Education:  MS in Life Science field or equivalent  2 or more years of experience in Quality Assurance/Regulatory Affairs, technical and customer support in a medical device discipline preferred  2 or more years of experience in cell biology and/or tissue culture  2 or more years of experience in Assisted Reproductive Technology or Cytogenetics  Knowledge of GMPs, CFRs, USP, ISO 13485, CMDR, MDD 93/42/EEC, IVD D 98/79/EC, ISO harmonized standards (EN14971, EN 13408, EN 13824) preferred  Knowledge of quality control methodology, QA control systems and production methodologies preferred  Ability to obtain cooperation from other groups and lead cross functional teams  Experience with risk management and Failure Mode Effects Analysis (FMEA) preferred  Strong root cause analysis skills required  Proficient in Microsoft Word, Excel, PowerPoint, Outlook