Phil Grosky

About Phil Grosky

Over the last 17 years, I have been fortunate to be immersed, as a Quality Professional, in the development and manufacture of medical devices. Several of my employers are Fortune 500 companies. Years, of both customer interaction with Medical Professionals and production with some of the world\'s largest manufacturers of medical devices, have provided me invaluable experience in developing devices that help patients sleep well, assist in cancer diagnosis and help sustain life for patients in hospitals. I am always 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 sleep scenarios, including the invention of a 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.

Experience

1. Staff Quality Engineer

   BD

   Jul 2023 — Present · US

   Project Management - Leading Quality Assurance worsktream teams for inter company medical device manufacturing transfers- Development and documentation for Quality planning- Quality Management System review and gap assessment for movement of medical device manufacturing into ISO Certified manufacturing environments- Lead QA representative for Corporate acquisition due diligence- Effectively lead stakeholder review and project execution tasks- Lead and/or track Quality Compliance activities related to 3rd party and regulatory bodies- QMS Development including but not limited to; gap closure in design documentation between Design Authorities and contract manufacturing sites, customization of QMS procedures to accommodate both regulated and non-regulated products and production processes

Education

• UCLA Extension Medical Device Engineering

  Certificate, Engineering

  2014 — 2017

• Western High School

  Diploma, Math, Science

  1993 — 1997

Skills

• Photoshop
• Cross-Functional Team Leadership
• Research Project Management
• Iso 14971
• Fine Art
• Painting
• Root Cause Analysis
• Certified Quality Engineer (Cqe)
• Regulatory Reporting
• Failure Mode and Effects Analysis (Fmea)
• Gmp
• Iso Standards
• Speaking Engagements
• Management
• Customer Relations
• Profitability Analysis
• Product Marketing
• Statistical Process Control (Spc)
• Dmaic
• Engineering Drawings
• Manufacturing
• Microsoft Excel
• Powerpoint
• Risk Assessment
• U.s. Title 21 Part 11
• Complaint Management
• Quality Management
• Staff Training
• Project Management
• Solidworks
• Technical Analysis
• Product Management
• Lean Manufacturing
• Lean Six Sigma
• Trade Shows
• Research Design
• Medical Devices
• Creative Problem Solving
• Change Control
• Dental