Amelia (Mali) Mottet has experience in Quality and Design Assurance. Mali has 5 years of experience in Design Assurance. She has worked for a mid-size contract R&D and manufacturing company and supported programs for Class I and II medical devices for start-up, mid-size, and large medical device companies. Additionally, Mali has supported large company QMS (Quality Management System) harmonization programs. Her career has been centered around Design Assurance and Quality Compliance, with a focus on ISO14971, ISO13485, 21CFR 820, MDR (Medical Device Regulation).
- Supported new product development and facilitated the generation of risk management files in accordance with ISO14971.
- Developed and supported medical device manufacturing build plans and reports in accordance with good manufacturing practices (GMP) for clinical and commercial products.
- Created, managed, and executed test objectives, test plans, and schedules for pre-clinical testing, including formal design verification and has provided support on process validation activities.
- Supported CAPA investigations, notified body audit, and improvements to design control and risk management procedures.
- Supported remediation efforts for MDR submissions including updates to Risk Management Files.
- Created inspection sampling plans, oversee QC inspection, and investigated nonconformance reports.
Mali holds a B.S. in Biomedical Engineering from the University of Minnesota.
