Diana Grenier, senior consultant, has 18 years of experience in project and quality engineering, primarily in the design, qualification and manufacture of medical devices (guidewires, urological devices, and intravenous delivery systems).
She is proficient in the areas of: product, process, and test method validation; failure analysis, including complaint investigation; and auditing, including compliance to Quality System Regulations ISO 13485 and 21 CFR Part 820.
As a Quality Engineering Consultant, Diana has helped engineering, manufacturing and quality departments improve the quality and reliability of new and existing products, including:
- Review and approval of operating procedures, process validations (IQ, OQ, PQ) and Design Change Orders.
- Analyzing quality information and reviewing recommendations for adjustments to product designs, manufacturing processes, equipment and the quality system.
- Coordinating responses to observations, including implementation of CAPA plans resulting from customer audits and/or notified body inspections.
- Supporting validation of manufacturing processes transferred to facilities in the United States and Mexico.
As a Quality Engineering Manager and Principal Design Engineer, Diana has:
- Managed complaint, NCMR, CAPA, calibration systems (including failure analysis, trending and reporting), and a Reliability Test Laboratory – where she coordinated testing priorities and ensured completeness and accuracy of test data.
- Reviewed and approved test procedures and reports for design and manufacturing engineering groups.
- Assessed alignment between Quality objectives and goals, product specifications, drawings and test procedures.
- Managed the conversion of the sterilization process for disposable medical devices from EtO to radiation sterilization. She coordinated the activities of product, quality and sterilization engineering, including functional qualifications, biocompatibility testing and bioburden/subdose evaluations. In addition, she performed the qualification and phase-in of material changes required for the implementation of the sterilization conversion.
Diana received her BS in mechanical engineering, with a minor in management, from Tufts University, College of Engineering. She received her ASQ Certified Quality Engineer (CQE) (active through 2009) and held a Professional Engineer (PE) license in mechanical engineering from the NC Board of Engineers and Land Surveyors (active through 2008).
Office: (888) 33 – 13485 Ext. 5