Scott Bradley
Manager, Quality System Compliance at Candela Medical
- Role
- Manager, Quality System Compliance at Candela Medical
- Location
- Woburn, MA, US
- LinkedIn followers
- 500 followers
About Scott Bradley
I have a strong problem-solving foundation from a technical background. At Candela Medical, I reestablished the CAPA program, training cross-functional team members in root cause analysis, and facilitate the success of the program through constant monitoring, reporting to SVPs and improvements quarterly to system KPIs.In 2022 I added Candela\'s EU MDR program to my responsibility. I communicate weekly with all product teams that are preparing for EU MDR certification and provide the latest guidance through collaboration with our Regulatory Affairs team.At Magna Seating, the company that leads innovation through solutions such as Stow \'n\' Go, I performed A/B user surveys to better understand the customers ideal comfort and desired functionality in our seat systems.At Gentex, my focus has been on optimizing the comfort and performance of our liner systems to support our wide array of special forces units, and commercial markets.6+ years experience in highly regulated industrySpecialties: DFSS Certified Engineer, Six Sigma EngineerGD & T Standard ASME Y14•••94Unigraphics NX 8.0CATIA V5Solidworks 2013, 2016Medical Device Product Engineering, Medical Device Industry, Test Protocols, Regulated Industry, FDA, FMEA, Design control, Assembly process, engineering experience, part design, using solid 3d design, CAD, UX design, User Experience
Experience
Manager, Quality System Compliance
Jul 2023 — Present · Marlborough, MA, US
Education
Kettering University
BS, Mechanical Engineering
2006 — 2010
edX
Digital Product Management MicroMasters, Business Administration and Management, General
2017 — 2018
Skills
- Minitab
- UX
- Microsoft Word
- Manufacturing Engineering
- Dfss
- Microsoft Excel
- Automotive
- Leadership
- Wers
- Management
- Manufacturing Drawings
- Leadership Development
- Design for Manufacturing
- 2d Cad Drawing
- Manufacturing
- Continuous Improvement
- Microsoft Powerpoint
- Life Skills
- Manufacturing Modeling
- Catia
- Ppap
- Engineering
- Biomedical Engineering
- Fmea
- Product Management
- User Experience Design
- Automotive Engineering
- Cross-Functional Team Leadership
- Business Strategy
- Geometric Dimensioning & Tolerancing
- Rapid Prototyping
- Process Engineering
- Mechanical Engineering
- Unigraphics
- Wers Basic Curriculum Certified
- Solidworks
- Project Management
- Dfmea
- Computer-Aided Design (Cad)
- Gd&T
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