Heather Meyer
- Role
- Staff Quality Systems Specialist Ii at BD
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
About Heather Meyer
Strategic quality assurance leader with eleven years of experience driving quality…
Experience
Staff Quality Systems Specialist Ii
Jul 2017 — Present
Serve as compliance and remediation strategist for ISO 13485:2016, MDSAP, MDR/IVDR, and Usability Engineering - Responsible for SAP document control and the C2C learning management system across 14 sites within BD Diagnostic Systems worldwide - Lead QS team responsible for document control and C2C administration for BD Diagnostic Systems headquarters
Skills
- Quality Management
- Testing
- Biotechnology
- Manufacturing
- 21 Cfr Part 11
- Design Control
- Ce Marking
- Fda Gmp
- Continuous Improvement
- Iso
- Quality Assurance
- Life Sciences
- Molecular Biology
- Quality Control
- Trackwise
- Gmp
- Lims
- Immunology
- Sop
- Quality Auditing
- Iso 14971
- Lifesciences
- R&D
- Computer System Validation
- Medical Devices
- Change Control
- 21 Cfr
- Immunoassays
- Iso 13485
- Regulatory Affairs
- Gxp
- Quality System
- Technology Transfer
- Pcr
- V&V
- Glp
- Product Development
- Hardware Diagnostics
- Validation
- Root Cause Analysis
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