Statistical Engineer #85
Post Market Surveillance Engineer sought by Hologic, Inc. in Danbury, CT to investigate & resolve a variety of issues, including fulfillment, assay, & instrument complaints. Requirements a Bachelor's degree in Mechanical Engineering Technology or related field plus 1 year of experience with medical device quality system regulations in the healthcare device industry. 1 year of experience must include 1 year of experience with each of the following: regulatory obligations for compliance including 21 CFR 820.198 & 21 CFR 211; cGMP or ISO 13485 including documentation, audit, & post market surveillance; core QMS concepts, QMS architecture, & QMS improvement activities; working with complaint investigation, root cause analysis, identification & implementation of CAPAs; statistical tools including Six Sigma, Statistical Process Control, Natural Language Processing, or Data Mining; statistical software language (R or Python); summarizing data into graphs, charts & statistics using software; & analysis & signal detection in a large data set.
Ref job code 85.