Product Support Scientist

Product Support Scientist

Rochester NY 14626

6 Months

This is a contract position in the Operations Product Support team, located in Rochester, NY. This role supports validation activities for new products within a medical device manufacturing facility and requires the ability to work both independently and as part of a cross-functional team.

• Calibration traceability claim papers are documents that demonstrate and document that patient sample test results obtained on a VITROS system are traceable to the highest available reference material/system in the calibration hierarchy.
• This role will review current product calibration traceability papers, compare the content to "internal benchmark" papers to determine adequacy to the requirements outlined in ISO 17511.
• The required edits to make the papers fully compliant (versus the benchmark paper and the ISO 17511 standards) will be made, the rationale provided, and the revised paper will then be routed for approval (this will require some basic training on our Change Control system).
• It is expected that some of the papers will require only minor editing while others may require new statistically derived uncertainty estimates and therefore some familiarity with statistics and statistical software (Minitab, Excel) is strongly preferred.
• The candidate will update progress to the project core team on a routine basis.

• Bachelor's degree in a scientific field is required.
• Strong written and verbal communication skills with excellent attention to detail required.
• Proficiency in Excel required, with additional statistical analysis skills preferred.