Quality Assurance Engineer

Assists the Quality Assurance and Regulatory Affairs Manager in developing and maintaining a complete, comprehensive, and compliant quality management system that supports the manufacture and sourcing of medical products in FDA product device classes I and II and Health Canada Class I; currently excluding FDA Device Class III and Health Canada Device Class II, III, IV products.
Assists the Quality Assurance and Regulatory Manager with medical device company compliance to various regulatory agencies and regulations; specifically, the FDA and Health Canada: QSR and applicable cGMP’s, AMMI Sterilization Standards, OSHA, EPA and other federal, state and local regulatory agencies.
Assists Quality Assurance and Regulatory Affairs Manager in the compliance and maintenance of the quality management system.
Provides the quality engineering function assuring that products meet their intended use through product specification, continuous evaluation, and data analysis.
Provides the company-wide training in statistical techniques and quality science.
Directs technical and administrative personnel engaged in quality assurance activities.
Evaluates and provides for audits, corrective actions, preventive actions, and compliance verification of internal and external quality management systems and their functions.
Investigates, prepares, and maintains records for customer complaints with root cause analysis along with corrective action, preventive action, and effectiveness check.
Acts as a quality representative for customers and vendors.
Assures validation and compliance of our medical device products through our contract sterilization facilities and our sourced medical device products sterilization facilities.
Acts as a quality representative for customers and vendors.