Diana Grenier is Vice President of Quality Compliance at AlvaMed. Diana has more than 30 years of experience in project and quality engineering, primarily in the design, qualification and manufacture of medical devices. Her expertise is in management of QA and QMS projects, ensuring compliance to Quality System Regulations including ISO 13485, Medical Device Regulation 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:
- Reviewed and approved operating procedures, process validations (IQ, OQ, PQ) and Design Change Orders.
- Analyzed quality information and reviewed recommendations for adjustments to product designs, manufacturing processes, equipment and the quality system.
- Coordinated responses to observations, including implementation of CAPA plans resulting from customer audits and/or notified body inspections.
- Created, implemented, and managed CAPA systems, including investigation, root cause analysis, resolution, and effectiveness checks.
- Supported validation of manufacturing processes transferred to facilities in the United States and Mexico.
As a Quality Engineering Manager, 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.
- 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.
As a Quality Assurance Consultant, Diana has supported quality projects for both established and startup medical device companies, including:
- Supporting the creation and implementation of Quality Management Systems compliant with regulatory standards, including, but not limited to, ISO 13485, 21 CFR 820, MDD 93/42/EEC and EU MDR 2017/745.
- Preparing, performing, and participating in both internal and external audits.
- Managing document control for ISO 13485 Quality Management Systems.
Diana received her B.S. in mechanical engineering, with a minor in management, from Tufts University. 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).
