Robert Lahaderne, Mba

Robert Lahaderne, Mba Email and Phone Number

Director of Regulatory and Quality @ Nexpring Health
Mission Viejo, CA, US
Robert Lahaderne, Mba's Location
Mission Viejo, California, United States, United States
About Robert Lahaderne, Mba

Hi LinkedIn, I’m looking forward to connecting with you! Here’s a bit about me and my background.𝐁𝐎𝐑𝐍 𝐈𝐍 𝐒𝐀𝐍 𝐅𝐑𝐀𝐍𝐂𝐈𝐒𝐂𝐎 🌉I was born in San Francisco as the oldest of 3 and we moved a lot while growing up. This forced me to be comfortable with change and as an extrovert, it was easy to adapt. When it was time to choose a college major, I chose Physics since it aligned with my interest in all technical fields. This education taught me how to break down problems into their components with an understanding of the bigger picture. From Sonoma State, I landed an internship at a tech company in R&D. In my final year, I married the girl of my dreams, graduated with my B.S., and started a full-time engineering position. It was an awesome opportunity where I gained experience in technical leadership across R&D, Manufacturing, and Program Management. 𝐌𝐀𝐍𝐀𝐆𝐈𝐍𝐆 𝐐𝐔𝐀𝐋𝐈𝐓𝐘 𝐀𝐓 𝐌𝐄𝐃𝐓𝐑𝐎𝐍𝐈𝐂 📈Eventually, I was ready for a change and joined Medtronic in Quality. From there, I was promoted to lead a new quality group that developed and validated test methods. I wanted to hone my leadership skills, so I went back to school for an MBA degree. It led to a promotion where I managed a newly acquired international quality team. Here, I led and trained teams in quality, problem-solving, statistics, and root cause analysis. I learned that this was my passion.𝐋𝐄𝐀𝐃𝐈𝐍𝐆 𝐆𝐋𝐎𝐁𝐀𝐋 𝐐𝐔𝐀𝐋𝐈𝐓𝐘 𝐓𝐄𝐀𝐌𝐒 𝐅𝐑𝐎𝐌 𝐒𝐔𝐍𝐍𝐘 𝐒𝐎𝐂𝐀𝐋 ☀️We moved to SoCal, and I supported various startups with challenges that required quality design, problem-solving, remediation, test method development, and quality tools to increase yields and improve compliance. In each of these roles, I led international teams and developed the staff. I have led teams in implementing a quality system, securing ISO 13485 certifications, and remediating major non-conformances to achieve MDSAP certification. I have always been enthusiastic to build a culture of quality throughout the companies I’ve worked with, evangelizing the function through communication and training inside and outside of my various Quality teams.𝐋𝐄𝐓'𝐒 𝐂𝐎𝐍𝐍𝐄𝐂𝐓 𝐎𝐍 𝐋𝐈𝐍𝐊𝐄𝐃𝐈𝐍 🌎Outside of work, I enjoy spending time with my wife and our 2 incredible sons who are the pride of our lives. If you’re looking to chat with an experienced and energetic executive who excels at leading quality teams, and developing quality systems\ that align with business results, then we should definitely connect on LinkedIn.Thanks for reading my story,Robb

Robert Lahaderne, Mba's Current Company Details
Nexpring Health

Nexpring Health

View
Director of Regulatory and Quality
Mission Viejo, CA, US
Employees:
312
Robert Lahaderne, Mba Work Experience Details
  • Nexpring Health
    Director Of Regulatory And Quality
    Nexpring Health
    Mission Viejo, Ca, Us
  • Advantrix, Llc
    Quality Lead
    Advantrix, Llc
    Mission Viejo, Ca, Us
  • Persperion Diagnostics Inc.
    Sr. Director, Quality
    Persperion Diagnostics Inc. Jul 2023 - Present
  • Advantrix, Llc
    Quality Lead
    Advantrix, Llc Jan 2023 - Present
    *Advise corporate clients and institutions on improving quality systems in a challenging compliance environment* Provide quality system support, fractional leadership, design control, risk management, test development, and employee training, employing expertise with Class II and Class III medical devices
  • Rxsight, Inc.
    Vp Of Quality System
    Rxsight, Inc. Feb 2022 - Jan 2023
    Aliso Viejo, Ca, Us
    * Led project activities for the global leader in adjustable intraocular lens technology, ensuring alignment across departments reporting directly to CEO* Reviewed and planned quality systems, setting goals for, managing, and improving all aspects of product quality and corporate product quality systems; reorganized quality organization, increasing efficiency and saving on costs* Coached, trained, delegated, and set individual objectives for the Quality team and established project management methods to align across functions regarding regulations and efficient product development
  • Metronom Health
    Vp Of Quality And Regulatory Affairs
    Metronom Health Oct 2019 - Feb 2022
    Laguna Hills, California/San Diego, Us
    * Managed quality, regulatory, and clinical teams, growing international quality team; provided coaching, training, delegation, goal-setting, motivation, and discipline to 7 globally geographically dispersed direct reports* Designed regulatory and clinical strategy for an early-stage medical device company that focuses on developing an innovative continuous glucose monitor technology for people living with diabetes, securing US and EU approvals
  • Metronom Health
    Senior Director Of Quality
    Metronom Health Apr 2019 - Oct 2019
    Laguna Hills, California/San Diego, Us
    * Aligned quality systems and regulatory efforts to support planned product approvals worldwide, collaborating with R&D Department on design assurance, providing quality control to maintain manufacturing and materials, and establishing quality systems and document control that secured certifications for regulatory compliance
  • Jenavalve Technology, Inc.
    Director Of Quality
    Jenavalve Technology, Inc. Aug 2017 - Apr 2019
    Irvine, Ca, Us
    * Led US and UK Quality International organization, including product quality, manufacturing, and quality system management for a medical device company developing the first transcatheter heart valve technology* Managed 8 direct reports in total organization of 10-15, reporting to Vice President of Quality and Regulatory* Delivered root cause analysis for yield improvements to Regulatory and Operations, reducing defects; identified opportunities for quality improvements, managing product release, audit hosting and support, and internal auditing
  • Somnera
    Director Of Quality Assurance
    Somnera May 2016 - Aug 2017
    San Clemente, California, Us
    * Redefined the entire Quality System* Represents Quality Assurance during the Design Control and Design Review process through review and approval of the applicable Design Input, Design Output, Design Verification, Validation, and Design Transfer. * Official correspondent to the FDA and International Regulatory Agencies.* Manage the company’s clinical and regulatory strategies and associated submissions, including pre-clinical and clinical studies, related directly or indirectly to marketing and associated promotions of Company products worldwide.* Responsible for managing and maintaining the vendor supply chain that supports the Company.
  • Endologix Inc
    Senior Quality Manager
    Endologix Inc Sep 2013 - May 2016
    Irvine, Ca, Us
  • Medtronic Vascular
    Global Quality Manager, Design Assurance
    Medtronic Vascular May 2012 - Sep 2013
    Minneapolis, Mn, Us
  • Medtronic Vascular
    Design Assurance Engineering Manager
    Medtronic Vascular May 2010 - May 2012
    Minneapolis, Mn, Us
  • Medtronic Vascular
    Prin. Design Assurance Engineer
    Medtronic Vascular Aug 2005 - May 2010
    Minneapolis, Mn, Us
  • Jds Uniphase
    Program Manager
    Jds Uniphase Oct 2002 - Aug 2005
    Chandler, Arizona, Us
  • Spectraswitch
    Sr. Process Engineer
    Spectraswitch Sep 2000 - Apr 2001
  • Jds Uniphase
    Process Engineer
    Jds Uniphase Nov 1997 - Sep 2000
    Chandler, Arizona, Us
  • Jds Uniphase
    Research Engineer
    Jds Uniphase Feb 1995 - Nov 1997
    Chandler, Arizona, Us

Robert Lahaderne, Mba Skills

Team Building Quality System Design Control Medical Devices Cross Functional Team Leadership Product Development Lean Manufacturing Six Sigma R&d Quality Assurance Iso 13485 Spc Design Of Experiments Fda Validation Iso 14971 Supplier Quality Product Launch Design For Manufacturing Black Belt Process Improvement V&v Statistics Workshop Facilitation Capa Root Cause Analysis Reliability Engineering Manufacturing Minitab Fmea Testing Dmaic Engineering Iso Biomedical Engineering Risk Analysis Value Stream Mapping Developing New Teams Developing Employees Change Management Project Portfolio Management Project Management Quality Control Change Control Gmp Leading Development Teams Technical Leadership Quality Auditing Ce Marking Quality Management

Robert Lahaderne, Mba Education Details

  • University Of San Francisco School Of Management
    University Of San Francisco School Of Management
    General Business
  • Sonoma State University
    Sonoma State University
    Physics

Frequently Asked Questions about Robert Lahaderne, Mba

What company does Robert Lahaderne, Mba work for?

Robert Lahaderne, Mba works for Nexpring Health

What is Robert Lahaderne, Mba's role at the current company?

Robert Lahaderne, Mba's current role is Director of Regulatory and Quality.

What is Robert Lahaderne, Mba's email address?

Robert Lahaderne, Mba's email address is ro****@****ail.com

What is Robert Lahaderne, Mba's direct phone number?

Robert Lahaderne, Mba's direct phone number is +170779*****

What schools did Robert Lahaderne, Mba attend?

Robert Lahaderne, Mba attended University Of San Francisco School Of Management, Sonoma State University.

What are some of Robert Lahaderne, Mba's interests?

Robert Lahaderne, Mba has interest in Kids, Cooking, Exercise, Economic Empowerment, Politics, Electronics, Education, Home Improvement, Reading, Science And Technology.

What skills is Robert Lahaderne, Mba known for?

Robert Lahaderne, Mba has skills like Team Building, Quality System, Design Control, Medical Devices, Cross Functional Team Leadership, Product Development, Lean Manufacturing, Six Sigma, R&d, Quality Assurance, Iso 13485, Spc.

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