COVIDIEN – $81,286.00/Year

The Supplier Quality Engineer position requires a Masters degree in Mechanical, Industrial or Biomedical Engineering and 1 year of experience in Supplier Quality Engineering. The position requires a minimum of 1 year of experience with each of the following supplier quality engineering for medical devices; FDA QSR Quality System Regulation and ISO 13485; quality system process documents, records and regulatory audits; CAPA Corrective and Preventive Actions; Lean Six Sigma and GMP Good Manufacturing Practices; risk activities, validation, methodical problem solving, product design and manufacturing engineering; development protocols including IQ, OQ, PQ Installation Qualification, Operational Qualification, a Performance Qualification, Special Process Validations, and Test Method Validations; and measurement uncertainty, GDT, Gauge Repeatability and Reproducibility.