staff quality engineer asq-cqe at bd@ BD
San Diego, California, United States
Phil Grosky
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FlashIntel GPTPhil Grosky is a highly experienced Quality Professional with over 24 years of work experience in the medical devices industry. He has a strong background in FDA regulations, ISO 13485, manufacturing, and product development. Phil has worked with renowned manufacturers such as Leica Biosystems and Abbott, where he has contributed to the development and manufacturing of medical devices. He is dedicated to continuous improvement and has a deep understanding of FDA regulations. Phil's focus is on quality and continuous improvement, and he has been faced with the FDA to address V&V, CAPA, complaints, and MDR with zero findings.
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About
Over the last 17 years, I have been fortunate to be immersed, as a Quality Professional, in the development and manufacture of medical devices. Years, of both customer interaction with Medical Professionals and production with one of the world's largest manufacturers of medical devices, have provided me invaluable experience in developing devices that help patients sleep well and Doctors make informed treatment decisions for cancer. I am continually working to further my wisdom in all aspects of quality, design and production improvement. I've had the privilege of speaking at Pepperdine, introducing Dentists to various treatment devices for sleep. I was able to help create custom solutions for achieving efficacy in difficult dental scenarios, including a patent pending device for the treatment of OSA. My focus has always been in Quality and Continuous Improvement. I have been face to face with the FDA to address V&V, CAPA, complaints and MDR with zero findings. I hold my Faith and my Family in the highest regard.
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staff quality engineer asq-cqe at bd
Medical Equipment Manufacturing
Phil Grosky's Professional Milestones
- Product Development Specialist (2004-04-01~2011-07-01): Driving product development initiatives and maximizing brand visibility through implementation of innovative solutions.
- senior quality engineer asq-cqe (2020-03-01~2021-11-01): Optimized quality control processes, resulting in higher product standards and enhanced customer satisfaction.
Skill
Medical Devices
Fda
Iso 13485
Manufacturing
Product Development
Quality System
Sleep Apnea
Engineering
Quality Assurance
Iso 14971
Cross Functional Team Leadership
Product Management
Solidworks
Powerpoint
Iso Standards
Project Portfolio Management
Quality Management
Rapid Prototyping
Market Research
Complaint Management
Visio
Risk Assessment
Regulatory Reporting
Cad
Quality Auditing
Staff Training
Speaking Engagements
Research Design
Patent Analysis
Patent Development
Engineering Drawings
Quality Systems
Corrective And Preventive Action
Lean Manufacturing
Lean Six Sigma
Microsoft Office
Microsoft Excel
Continuous Process Improvement
Verification And Validation
Failure Mode And Effects Analysis
Statistical Process Control
Root Cause Analysis
Project Management
Data Analysis
Dmaic
Change Control
Gmp
Management
Certified Quality Engineer
U.s. Title 21 Part 11
Trade Shows
Technical Analysis
Report Writing
Microsoft Word
Certification
Colleagues
Other Named Phil Grosky
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Phil Grosky works for BD
Phil Grosky's role in BD is staff quality engineer asq-cqe at bd
Phil Grosky works in the industry of Medical Equipment Manufacturing
Phil Grosky's colleagues are Dharmendra Kumar,Bayzid Hasan,Sammy Beck
Phil Grosky's latest job experience is staff quality engineer asq-cqe at bd at BD
