COVIDIEN – $69,139.00/Year

Requires a Bachelors degree in Mechanical or Biomedical Engineering or related engineering field and six 6 months of experience in Quality Engineering.br br Must possess six 6 months of experience in the followingbr br Quality engineering for medical device componentsbr 21 CFR Part 820 Quality System Regulation QSR, ISO 13485, European Union EU Medical Device Regulation MDR, and Good Manufacturing Practices GMPbr Risk Assessments, Process Failure Modes and Effect Analysis PFMEAbr NonConformances, Corrective and Preventive Actions CAPAbr Process Improvement Tool, DMAIC strategies LEAN Six Sigma methodologies, Root Cause Analysis RCA, 5Whys, Fishbone and cause mappingbr DOE methods to establish process developmentbr Statistical analysis tools for process capability CpkPpk, ANOVA, Gage RR, SPC, Attribute Agreement Analysis and TMVbr Development of VV, IQ, OQ, and PQ