Al Young

Al Young Email and Phone Number

Medical Device Quality Assurance & Regulatory ConsultingASQ Certified & RAPS Professional @ InCube Labs
Al Young's Location
San Francisco Bay Area, United States, United States
Al Young's Contact Details

Al Young personal email

n/a

Al Young phone numbers

About Al Young

ASQ Certified Professional in Quality & Reliability Engineering with 15 plus years experience in the medical device industry and successful career experience in the launch of several 510k and PMA product introductions. Professional experience as a Quality Engineer, Manager, and Director with vast product experience with medical device disposables and reusables, implants, laser and RF therapy systems, and radiation delivery systems for the treatment of cancer. Demonstrated industry expertise in the following areas:1) Design Control & Design Reliability Assurance2) Quality Statistics & Design of Experiments (DOE's)3) Design Verification & Process Validation4) Biocompatibility & Sterilization (ETO, gamma, steam)5) Product Shelf Life Testing6) Customer Complaint Handling and Product Failure Analysis7) Product Risk Management 8) FDA Quality System Regulations, EU MDD and Health Canada Regulations9) ISO 13485:2016, ISO 14971, IEC 60601 & 62304 Standards, MDSAP10) EU Environmental Regulations for RoHS, WEEE and REACH11) Quality System and supplier auditingSpecialties: Quality Statistics, Design of Experiments, FMEA's, Fault Treee Analysis (FTA's), process validation, product sterilization methods (ETO, gamma, autoclaving)

Al Young's Current Company Details
InCube Labs

Incube Labs

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Medical Device Quality Assurance & Regulatory ConsultingASQ Certified & RAPS Professional
Al Young Work Experience Details
  • Incube Labs
    Director Of Quality Assurance
    Incube Labs Jun 2019 - Present
    San Jose, Ca, Us
  • Xoft, Inc.
    Director Of Quality Assurance & Regulatory Affairs (Management Representative)
    Xoft, Inc. Jul 2013 - 2019
    San Jose, Ca, Us
  • Covidien
    Quality Engineering Manager
    Covidien Mar 2012 - Jul 2013
    Fridley, Minnesota, Us
  • Solta Medical
    Principal Quality Engineer
    Solta Medical Jun 2011 - Mar 2012
  • Medtronic Spinal & Biologics
    Principal Quality/Reliability Engineer
    Medtronic Spinal & Biologics Jun 2008 - Jun 2011
  • Medtronic Neurosurgery
    Quality Engineer Manager
    Medtronic Neurosurgery Dec 2005 - Dec 2006

Al Young Skills

Iso 13485 Design Control Medical Devices V&v Design Of Experiments Iso 14971 Fda Fmea Quality Assurance Quality System Validation Capa Quality Control Biomedical Engineering Six Sigma Lean Manufacturing Gmp Manufacturing R&d Supplier Quality Root Cause Analysis Testing Dmaic Product Development Iso 21 Cfr Part 11 Minitab Spc Continuous Improvement Failure Analysis Design For Manufacturing Ce Marking Manufacturing Engineering Gage R&r Corrective And Preventive Action Research And Development Verification And Validation

Al Young Education Details

  • San José State University
    San José State University
    Electrical Engineering
  • City College Of San Francisco
    City College Of San Francisco
    Associate In Science Electronics Engineering Technology

Frequently Asked Questions about Al Young

What company does Al Young work for?

Al Young works for Incube Labs

What is Al Young's role at the current company?

Al Young's current role is Medical Device Quality Assurance & Regulatory ConsultingASQ Certified & RAPS Professional.

What is Al Young's email address?

Al Young's email address is al****@****ast.net

What is Al Young's direct phone number?

Al Young's direct phone number is +140849*****

What schools did Al Young attend?

Al Young attended San José State University, City College Of San Francisco.

What skills is Al Young known for?

Al Young has skills like Iso 13485, Design Control, Medical Devices, V&v, Design Of Experiments, Iso 14971, Fda, Fmea, Quality Assurance, Quality System, Validation, Capa.

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