Eric Bash Email and Phone Number
Chapel Hill, NC, US
Eric Bash's Location
Raleigh-Durham-Chapel Hill Area, United States, United States
Eric Bash's Contact Details
Eric Bash work email
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Eric Bash personal email
n/a
Eric Bash phone numbers
About Eric Bash
With over 15 years of quality experience in both medical devices and naval nuclear power, I am a certified and accomplished quality manager at Gilero, a leading contract design and development company for medical devices. I have expertise in CAPA, New Product Development, Sustaining Engineering, Personnel Management, and EU MDR requirements, as well as certifications in Quality Engineering, Medical Device Auditing, and Systems Engineering.At Gilero, I have performed internal audits, led quality and regulatory activities for multiple drug-led combination devices, contributed to securing $20M+ in contracts, and mentored and developed a team of five quality engineers. I have also overhauled the risk management and management review processes to align with the latest industry standards and best practices, resulting in significant efficiency and quality improvements. I am passionate about creating a strong quality culture, anticipating and solving problems, and delivering reliable and compliant products that meet customer needs and expectations.
Eric Bash's Current Company Details
Gilero, A Sanner Group Company
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Sr Manager, Design and Development Quality Engineering
Chapel Hill, NC, US
- Website:
- gilero.com
- Employees:
- 130
Eric Bash Work Experience Details
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Sr Manager, Design And Development Quality EngineeringGilero, A Sanner Group CompanyChapel Hill, Nc, Us
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Design And Development Quality ManagerGilero Mar 2023 - PresentDurham, North Carolina, Us*Performed internal audits of multiple international facilities to ensure ISO 13485 and 21 CFR Compliance*Quality and regulatory lead on multiple drug-led combination devices*Key contribution to D&D proposals leading to acquiring $20M+ in contracts*Lead, mentor and develop 6 direct reports in quality engineering, software quality engineering, and laboratory facilities*Overhaul of risk management techniques to align to latest ASQ guidance*Overhaul of management review to focus on actionable information, resulting in an 80% reduction in required engineer-hours
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Quality Engineering ManagerTerarecon, Inc. Jul 2022 - Mar 2023Durham, North Carolina, Us*Performed internal audits as lead auditor on multiple quality subsystems including installation, service, and manufacturing*Developed ISO 14971:2019 compliant risk management system*Managed company through a 63% improvement in CAPA timeliness*Developed IEC 62366-1 human factors validation program -
Sr. Quality Systems EngineerTerarecon, Inc. Sep 2021 - Jul 2022Durham, North Carolina, Us*Performed detailed gap analysis to assess compliance to MDR article 120(3)*Overhauled complaints statistical trending techniques for management review on a quick turn within 1 week of gap identification*Further overhauled all of management review to use statistically valid techniques*Developed process validation procedure, instruction and forms*Developed nonconformity documentation and investigation processes as feeder to CAPA system*Developed distributor supplier agreement template*Overhauled CAPA system to make use of CAPA review boards and formalize investigation process*Overhauled supplier management processes to align with GHTF guidance*Performed risk based qualification of multiple SaaS providers impacting QMS*Overhauled Risk Management, Cybersecurity Management, and Clinical Product Development to be compliant with latest regulations, standards and industry best practice
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Senior Quality EngineerTeleflex Incorporated Jul 2020 - Sep 2021Wayne, Pa, Us*Developed and presented company-wide training on Usability and Systems Engineering*Partnered with R&D management to develop best practices for capital device new product development -
Mdr Quality EngineerTeleflex Incorporated Jul 2019 - Jul 2020Wayne, Pa, Us*Development of Post-Market Surveillance Plans for Class I and II devices.*Development of IEC 62366-1 Usability Files to include Annex C compliance documents (UOUP)*Review and update of Risk Management Files*Hazardous materials identification per EU Harmonized hazardous substances
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New Product Development Quality EngineerConmed Corporation Jul 2017 - Jul 2019Largo (Tampa Bay), Fl, Us*Cross-functional engineering leadership to ensure efficient integration between mechanical, software and electrical disciplines*Manage requirements, verification and validation, design history file, requirements management software, and conduct design assurance phase gate reviews*Architected IEC 62304 software quality assurance program to include iterative quality processes in Agile development*Architected IEC 62366-1 usability engineering program -
Quality Engineer IiConmed Corporation May 2017 - Jul 2017Largo (Tampa Bay), Fl, Us* Recognized as an exemplary performer who sets the example for others to emulate. Further, instrumental in changing ConMed culture to a more efficient and effective quality system.* Coordinated with remote production and distribution centers to implement corrective actions for non-conforming product as well as to quarantine and dispose of non-conforming product* Participated in eight CAPA Investigations, leading three* Performed four technical studies and assisted in risk analysis for new product lines* Directly interacted with customers to resolve system level issues
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Quality Engineer IConmed Corporation Aug 2016 - May 2017Largo (Tampa Bay), Fl, UsAggressively sought out improvements - Implemented a procedure to minimize wastage in returned devices, affecting a cost savings of $36,000 over three months. Developed organizational system for returned product, minimizing factory footprint and improving the complaint group’s ability to find and track returned product. Vital in MDSAP audit preparation, improving overall audit readiness through strategy recommendation and personnel training.Improved Customer Relations - Developed a procedure for complaint trending to ensure that trending is performed in a uniform fashion across the company. Developed semi-automated system for complaint completion tracking in response to an error in calculating days open in previous manual system. Trained 4 operators to preform evaluations in returned devices evaluation cell.Investigated product deficiencies - Performed engineering analysis of carbide burs and electrodes with polyethylene shrink tubing, identifying and documenting potential risks. Personally performed 70 complaint device evaluations to minimize backlog after sudden personnel transition. Assisted in Complaint System Investigator workload by personally completing 47 Preliminary investigations
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Reactor Control Division Leading Petty OfficerUs Navy Sep 2015 - Jul 2016Washington, Dc, UsDuties:- Train, mentor and develop members of six man division: Took a supervisory role in the Reactor Control Audit and Surveillance program, molding the next generation of sailors into safe, knowledgeable operators and technicians. Recognized as instrumental in creating a culture of knowledgeable and gifted operators who aggressively seek out resolution to problems.- Provide supervision ensuring completion all required maintenance in high tempo upkeep periods: Provided direction and supervision allowing Reactor Control division to accomplish 56 preventative and eight emergent corrective maintenance items, highlighted by repairs to three major Reactor Plant Instrumentation systems.- High level planning: Coordinated with other Work Center Supervisors to de-conflict multiple complex maintenance items requiring in excess of one week to complete, ensuring efficient completion of all required maintenance during an upkeep period.- In-process quality control supervision to maximize longevity of components: Developed and supervised the use of a four page wire removal and replacement document required for repair of shipboard electrical distribution equipment. Acted as cleanliness inspector for reactor plant and steam plant maintenance, establishing and maintaining cleanliness as required to ensure no system degradation from foreign contaminants could occur.Accomplishments:- Quality Assurance Maintenance Planner Qualification- Reactor Plant Cleanliness Inspector qualification- Steam Plant Cleanliness Inspector qualification- Directly contributed to USS Wyoming receiving the USSTRATCOM Omaha Trophy and SUBRON 20 Battle Efficiency 'E'.Related Skills:- In-process quality control- Training- Availability planning- System cleanliness -
Reactor Plant Primary Maintenance SupervisorUs Navy Jan 2014 - Sep 2015Washington, Dc, UsDuties:- Plan, schedule and supervise preventative and corrective maintenance on Reactor Instrumentation and Control Electronics: Planned the successful execution of 20 annual, 25 semiannual and five emergent corrective maintenance items, in addition to an alteration to major shipboard electrical equipment.- Improve maintenance and troubleshooting processes: Significantly improved the Reactor Control Division Troubleshooting guide by writing guides for system faults and fixing numerous discrepancies.- Troubleshoot and repair Reactor Instrumentation and Control Electronics: During Fleet Commander's inspection, rapidly diagnosed a simulated fault causing reactor shutdown within 30 minutes that was not covered in the Reactor Control troubleshooting guide, quickly and efficiently restoring the reactor plant to full operation.- Maintain reactor plant quarterly usage data: Flawlessly maintained critical data records associated with reactor plant operation and maintenance receiving high marks during the Fleet Commander's inspections.- Schedule work for six man divisionAccomplishments:- Electronics Technician Maintenance Specialist Certification: Certified to make and inspect solder joints to Naval Nuclear standard.- Navy and Marine Corps Achievement Medal - Developed troubleshooting plan for a complex fault and personally affected the two required repairs within 24 hours allowing ship to meet operational commitments- Directly contributed to USS Wyoming receiving the U.S. Fleet Forces Arleigh Burke trophy and SUBRON 20 Battle Efficiency 'E'.- Sea service ribbon for Patrol 52 for continuous time at sea in excess of 90 days.- Led a Lay leader program recognized by SUBRON 20 for its professionalism and excellence, doubling shipboard attendance.Related Skills:- Maintenance planning- Maintenance supervision- Record Keeping- Complex System Troubleshooting
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Electronics Technician (Nuclear)Us Navy Jul 2012 - Jan 2014Washington, Dc, UsDuties:- Operate a pressurized water nuclear reactor on rotating shift work: Within weeks of qualification was trusted to stand watch during complex plant evolutions and successfully perform them flawlessly. Performing at this level rapidly eased the transition of senior personnel rotating out of the command.- Radioactive Contamination Worker: Responded to multiple radioactive spills to fully remove loose surface contamination and provide measurements of loose surface contamination, extent of spread and amount which had gone airborne.- Perform preventative maintenance on Reactor Instrumentation and Control electronics- Provide for ship's physical security- Respond to ship's casualties for damage control efforts Accomplishments:- Selected as lead firefighter and pipe repair person: Applied a pipe patch in a confined space requiring high manual dexterity restoring full defensive weapons system capability within 5 minutes after a simulated casualty. Demonstrated response times under 1 minute in full firefighting ensemble to simulated shipboard fires.- Enlisted Submarine Warfare QualificationRelated Skills:- Firefighting- Preventative maintenance- Operation of complex systems- Testing of electronic systems- Testing of hydraulic systems
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Nuclear Field StudentUs Navy Jul 2010 - Jul 2012Washington, Dc, UsRigorous study of topics required for nuclear plant operation and nuclear electronics maintenance. Topics covered included but are not limited to Nuclear Physics, Nuclear Reactor Technology, Health Physics, Reactor Principles, Electronic Power Supplies, Electronic Amplifiers, Solid State Electronics, and VME Architecture.
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Resnet Computer ConsultantEmbry-Riddle Aeronautical University Jul 2006 - May 2010Daytona Beach, Florida, UsDuties:-Performed system testing on network cabling in over 500 dorm rooms, repairing as required. Installed network switchgear for Apollo Hall to include cable connections with associated record keeping. - Performed repairs on over 400 personally owned student computers. Recovered term papers from failed hard drives and ensured students were able to focus on their studies and not technical problems with their equipment.- Co-authored scheduling system for an eight person staff, providing for preferred hours based on seniority.Skills:- Computer hardware and software repair- Byte level HDD repair- Forensic, non-destructive removal of malware
Eric Bash Skills
Electrical Troubleshooting
Soldering
Electronics Repair
Computer Repair
Java
Numerical Simulation
Catia
System Testing
C
Sql
Matlab
Record Keeping
Maintenance Planning
Management
Job Scheduling
Preventive Maintenance
Computer Hardware Troubleshooting
Leadership
Personnel Management
Employee Training
Electronics
Sketchup
Microsoft Office
Hand Drafting
Scuba Diving
Maintenance And Repair
Security Clearance
Navy
Simulations
Military
Aerospace
Military Experience
Troubleshooting
Integration
Maintenance
Dod
Military Operations
Eric Bash Education Details
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Embry-Riddle Aeronautical UniversitySystems Engineering -
Embry-Riddle Aeronautical UniversityAeronautical And Astronautical Engineering
Frequently Asked Questions about Eric Bash
What company does Eric Bash work for?
Eric Bash works for Gilero, A Sanner Group Company
What is Eric Bash's role at the current company?
Eric Bash's current role is Sr Manager, Design and Development Quality Engineering.
What is Eric Bash's email address?
Eric Bash's email address is er****@****con.com
What is Eric Bash's direct phone number?
Eric Bash's direct phone number is +190446*****
What schools did Eric Bash attend?
Eric Bash attended Embry-Riddle Aeronautical University, Embry-Riddle Aeronautical University.
What are some of Eric Bash's interests?
Eric Bash has interest in Animal Welfare.
What skills is Eric Bash known for?
Eric Bash has skills like Electrical Troubleshooting, Soldering, Electronics Repair, Computer Repair, Java, Numerical Simulation, Catia, System Testing, C, Sql, Matlab, Record Keeping.
Who are Eric Bash's colleagues?
Eric Bash's colleagues are Adan Espinoza, Chandler Sizer, Sayed Noorullah Peerzade, Vicki Lemley, Graham Bass, Wade Stauffer, Maggie Walker.
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