Dale Gloyeski
Director at Pristine Surgical- Claim this Profile
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Bio
Credentials
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ASQ CQA
ASQ
Experience
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Pristine Surgical
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Director
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Jan 2023 - Present
Pristine Surgical is a medical device company with a mission to simplify endoscopy. Pristine Surgical combine single-use endoscopes with cloud-based software to make minimally invasive visualization more efficient, consistent, and safe. We offer a unique subscription business model with transparent pricing and automated inventory management, delivering improved workflow and reduced costs to the endoscopy suite. Pristine Surgical is a medical device company with a mission to simplify endoscopy. Pristine Surgical combine single-use endoscopes with cloud-based software to make minimally invasive visualization more efficient, consistent, and safe. We offer a unique subscription business model with transparent pricing and automated inventory management, delivering improved workflow and reduced costs to the endoscopy suite.
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AbbVie
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Assoc. Director TPM (Third Party Manufacturing)
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Jan 2021 - Jun 2023
Manage TPM's in the production of medical devices. Work in collaboration with Commercial and Technical Team in qualification and release of new medical devices at TPM's. Manage TPM's in the production of medical devices. Work in collaboration with Commercial and Technical Team in qualification and release of new medical devices at TPM's.
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Advanced Sterilization Products
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Senior Manager Operations Engineering
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Apr 2017 - Mar 2022
Senior Operations Engineering Manager at ASP. In this role I provide functional management and technical leadership for the Operations Engineering group. Supervision of the OE group for coordination and the application of scientific techniques and Process Excellence (six sigma) techniques to design and develop safe, effective and efficient processes and products in support of the company’s strategic plan. Leading complex projects requiring cross-functional support and participation with emphasis in molded plastic, precision machining, and/or electromechanical process/products. Show less
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Biosense Webster
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Quality Operations Manager
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2015 - 2017
Management of Quality Engineering Staff for manufacturing in-process, verification and packaging activities. Management of RI Leads and Inspectors to complete part\component, FAI inspections. Management FGI Lead and Inspectors for Pre-Sterilization and Post-Sterilization Product Release activities. Management of NC System for Product and Processes. Accomplishments: • Management, process testing improvements of Irrigation Tubing that removed products off allocations and lead to acceptable levels of safety inventory. • Management of Proactive FGI Report for tracking Catheter Load Micro-Biological and Final Release activities. • Management of NC system with Proactive Report that reduced NC closure time meeting Metrics. • Creation and Management of Product C of C Process for International Ministries of Health. • Creation of Inspection Plans and Process for FGI of Externally Manufactured Products. • Creation and Management of Re-Labeling Activities for Shelf Life Extension Projects. • Creation of interim solution for ASL mismatches with Supplier provided documentation ( C of C’s, Shippers) Show less
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Advanced Sterilization Products
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Quality Systems Leader - Life Cycle Management
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2011 - 2015
Management of Life Cycle Management (LCM) Group of Advanced Sterilization Products, a Medical Device Company of Johnson and Johnson. Lead Team Members in technical resolution of Quality Issues for Products and Processes. Management of strategies that support goals and objectives for the maintenance and profitability of products over their useful lives. Collaborator with R&D and OPS Engineering to facilitate better Team performance and Product/Process outcomes.
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Quality Systems Leader - Supplier Quality
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2009 - 2011
Team Building and Talent Development for 5 Engineering Processionals. Management of External Supplier/Manufacturer Base (20 Manufacturers accounting for significant annual sales, 5 are International) for Quality Systems oversight. Management of Team responsible for Supplier Selection, Product Qualifications/Validations, Technical Transfers, conducting Quality System Audits/Reviews, Disposition of NC’s and Product Sustaining Engineering.
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Quality Systems Leader - Receiving Inspection
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2007 - 2009
Team Building and Talent Development for 9 Quality Systems Professionals. Management of Receiving Inspection Department for product inspections and release. Facilitation of Device History reviews (DHR) for Systems release. Management of Complaints Handling Lab responsible for testing and documentation of Complaint Returned Items. Management of Calibration Department and Preventative Maintenance System. Customer Experience Complaints Handling Lab creation, set-up and management.
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Quality Systems Staff Engineer
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2005 - 2007
Responsible for Quality Systems oversight for External Suppliers/Manufacturers (9 Total). Completion of Validation/Qualification of products for sustaining engineering purposes. Completion of periodic audits and quality reviews of External Manufacturers. Technical transfer of Medical Devices into Supplier Production.
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Operations Engineer
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2003 - 2005
Management of Equipment design, build, implementation supporting new and existing products/processes. External Manufacturer support for improvement and optimization of manufacturing processes. Molded product process development and qualification.
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Allergan
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior Manufacturing Engineer
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1999 - 2003
Successful Projects include: State-of-the-Art Cataract Extraction System DFM Assessment and Technical Transfer to 3rd Party Manufacturer. Specification/Design/Installation Automated Silicone Lens Finishing System with Robotic Assist. Cyro-Tumbling Equipment (Lens Polishing) Specification, Fabrication and Validation. Fluidics Cartridge Pack Silicone Aspiration Tube Design Implementation. Leak Detection System Specification, Fabrication and Validation for Fluidics Cartridge Packs. Successful Projects include: State-of-the-Art Cataract Extraction System DFM Assessment and Technical Transfer to 3rd Party Manufacturer. Specification/Design/Installation Automated Silicone Lens Finishing System with Robotic Assist. Cyro-Tumbling Equipment (Lens Polishing) Specification, Fabrication and Validation. Fluidics Cartridge Pack Silicone Aspiration Tube Design Implementation. Leak Detection System Specification, Fabrication and Validation for Fluidics Cartridge Packs.
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3M
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United States
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Industrial Machinery Manufacturing
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700 & Above Employee
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Senior Manufacturing Engineer
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1997 - 1999
Specification/Installation/Validation high torque/viscosity capable planetary mixer. Silicone Dual Syringe Filling System automation upgrade and redesign. Redesign of Vibratory Bowl for Laser Marking System of Cartridge Product. Design/Installation/Validation Automated Silicone Syringe Packaging Line. Design/implementation of automatic recipe mixer control for Restorative Product. Trouble-shooting manufacturing processes for improvement and optimization. Specification/Installation/Validation high torque/viscosity capable planetary mixer. Silicone Dual Syringe Filling System automation upgrade and redesign. Redesign of Vibratory Bowl for Laser Marking System of Cartridge Product. Design/Installation/Validation Automated Silicone Syringe Packaging Line. Design/implementation of automatic recipe mixer control for Restorative Product. Trouble-shooting manufacturing processes for improvement and optimization.
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B. Braun Medical Inc. (US)
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Senior Engineer
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1993 - 1997
Development, specification design of Intravenous Container Form Film Seal Machine utilizing proprietary non-PVC film. Irrigation Container equipment development, specification, build, implementation and validation through PMA FDA submission. TPN container filling unit specification, design, build, installation and validation for Customer. Engineering support of blood expansion (100 ml container) product for FDA PMA submission. Development, specification design of Intravenous Container Form Film Seal Machine utilizing proprietary non-PVC film. Irrigation Container equipment development, specification, build, implementation and validation through PMA FDA submission. TPN container filling unit specification, design, build, installation and validation for Customer. Engineering support of blood expansion (100 ml container) product for FDA PMA submission.
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Education
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Purdue University
Bachelor's Degree, Mechanical Engineering -
Azusa Pacific University
Master's Degree, Business Administration and Management, General
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