Tiea Theurer
Helping Medical Devices, including IVDs, achieve their strategies, objectives, and goals | EU MDR and IVDR | FDA | MDSAP | SaMD | ISO 13485, 9001, 17025, and 27001 | Auditor, Educator and Consultant
- Role
- Auditor at RQM+
- Location
- Newark, DE, US
- LinkedIn followers
- 500 followers
About Tiea Theurer
Are you a start-up who need assistance implementing a Quality Management System or preparing regulatory documentation? Is your internal audit program not working for you? Are you a SaMD or a SaaS who needs to implemented cybersecurity controls?Are you a test or calibration service who needs audits?Are you struggling to maintain internal competency? Do you feel overwhelmed with the maintaining compliance country regulation and industry standards?If so, I can help.I have worked with multiple start-up companies implementing a quality system or creating product documentation for regulatory submissions. I have worked with many technologies such as imaging, in vitro, sterilization, plastics, SaaS, SaMD, general medical devices, I have many years of experience conducting audits for ISO 13485, ISO 9001, ISO 17025, ISO 27001, and country regulations such as MDR, IVDR, US, Canada, Brazil, Japan, Australia, China, UK, Switzerland. I educate companies on quality system topics of design control, risk management, process validation, CAPA and country regulations such as MDR, IVDR, US QMSR.I have experience working through the FDA regulatory paths of PMA, De Novo and 510(k) cleared in order to place products on the marketSend me a DM on here to find out more about collaborating with me and Quarem Consulting#MedicalDevice #InVitro #QualitySystems#RiskManagment #Auditing #CalibrationTestingServices #Cybersecurity #InformationManagementSystem #Quarem #QuaremConsulting #Teaching
Experience
Auditor
Dec 2023 — Present
Education
Indiana University Indianapolis
MPA, Public Affairs
1997 — 2001
Indiana University Indianapolis
Master of Public Administration - MPA
Purdue University
BS, Medical Technology
1987 — 1991
Skills
- Lean Manufacturing
- Verification and Validation (V&V)
- Fmea
- Qsr
- Medical Devices
- Capa
- Failure Mode and Effects Analysis (Fmea)
- Process Improvement
- Project Management
- Documentation
- Iso 13485
- U.s. Food and Drug Administration (Fda)
- Design of Experiments
- Six Sigma
- Continuous Improvement
- Compliance
- 21 Cfr
- Quality Auditing
- Process Validation
- Data Analysis
- Quality System
- Quality Systems
- V&V
- Root Cause Analysis
- Process Simulation
- Quality Management
- Corrective and Preventive Action (Capa)
- Biomedical Engineering
- Risk Management
- Process Development
- Design Control
- Fda
- Iso 14971
- Dmaic
- Product Development
- Quality Assurance
- Validation
- Gmp
- Problem Solving
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