Paola S.
Medical Device Engineering Professional Medical Devices QMS Certified Lead Auditor - BSI
- Role
- Quality Assurance Manager Qa Engineer at Med-Logics, Inc
- Location
- Athens, TX, US
- LinkedIn followers
- 500 followers
About Paola S.
I’m an industrial designer qualified to develop concepts for manufactured products. My knowledge combines engineering, business and art to make products that people use every day. I am able to consider the function, quality requirements, aesthetics, production cost, and usability of products when developing new product concepts. Qualifications:Over 15 years of experience inside the medical devices field. Specialized on Interventional Radiology Class I, II and medical devices (10 mlsyringes, Skater Drainage Catheter Products, needles, and reusable biopsy devices, medical balloons for PTA (Percutaneous Transluminal Angioplasty catheters) Experienced engineer capable to lead and manage cross-functional projects that involve MDR Regulatory Submissions, Quality CAPA projects Product development that involves Manufacturing processes, such as extrusion, tipping, and validation of automatic equipment Specialties: Detail-oriented, analytical thinking, Development, Quality and regulatory Procedures during MDD - MDR submissions, documentation, CAPA investigations, process and resolution, design verification and design validations.
Experience
Quality Assurance Manager Qa Engineer
Aug 2024 — Present · US
Education
COL.SAGRADO CORAZON
JUNIOR HIGH, JUNIOR HIGH
1990 — 1993
Universidad Autónoma de San Luis Potosí
MASTER/SPECIALIST, FURNITURE DESIGN
2001 — 2002
COL. SAGRADO CORAZON
TECHNICAL, SOCIAL WORK TECHNITIAN AND HIGH SCHOOL
1993 — 1996
Universidad Autónoma de San Luis Potosí
Bachelor's degree, Industrial and Product Design
1996 — 2001
Skills
- Spanish
- Problem Solving
- Model Making
- Customer Service
- Sketching
- Industrial Design
- Technical Drawing
- Materials
- Packaging
- Marketing Strategy
- Photoshop
- Product Marketing
- Merchandising
- Data Analysis
- Product Design
- Photography
- Retail
- Microsoft Word
- Inventory Management
- Inventory Control
- Product Development
- Advertising
- Manufacturing
- Powerpoint
- Microsoft Excel
- Microsoft Office
- Sales
- Management
- Business Strategy
- Autocad
- Project Planning
- Furniture
- Medical Devices
- Purchasing
- Graphic Design
- Technical Documentation
- Rendering
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