Meghan Heldt
- Role
- Senior Labeling Specialist at Surmodics, Inc.
- Location
- Minneapolis, MN, US
- LinkedIn followers
- 500 followers
About Meghan Heldt
Professional Personality Assessments: DiSC Profile: High I/D Combo (Result-Oriented)…
Experience
Senior Labeling Specialist
Mar 2022 — Present
Propel PLM (Product Lifecycle management) Projects: • Assisted in the initial launch of Propel for Minnesota & Ireland Surmodics sites by writing quality system procedures, developing a go live training program, and participating in User Acceptance Testing (UAT). • Project Managed and assisted in the launch of Propel Quality Events (NCRs, CAPA, and Medical Device Complaints) for Minnesota & Ireland Surmodics sites by writing quality system procedures, developing training programs, and participating in User Acceptance Testing (UAT). Labeling Projects: • Updated processes and systems to streamline the label change process & global UDI policies. • Assisted in creating & developing a process and website for EU MDR • Assisted in label and IFU creation for new product launch with submissions to the FDA and BSI • Created Project Charter and team to standardized and implement new labeling software for Surmodics ISO Certifications: • ISO 13485:2016 Internal Auditor (TPECS)
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