Position specific responsibilities include support of the following, however are not limited to:
Identification of CTQ's
Unit Quality Independent Reviewer During Design Reviews
Handling of deviations and non-conformances
Test method validations
Post Market Surveillance
CAPA – Root cause investigation and implementation of corrective / preventive actions
Proper Use of Statistics (Sampling Plans)
Advise on Regulations
Liaise with Manufacturing Plants
Provide functional support to cross-functional teams
Internal and external audits
Training in statistics. Class II / III medical device experience (preferred). Knowledge of design control principles (preferred). Ability to provide support to internal / external audits.
Requires a minimum of a Bachelor’s Degree.