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Director of Quality Management & Engineering Resume Example

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DIRECTOR OF QUALITY MANAGEMENT & ENGINEERING
Summary

Incisive analytical leader with 10+ years of experience in ensuring quality of medical devices through the management of quality assurance teams and regulatory compliance to international and domestic standards. Recognized for ability to lead teams through all phases of complex product development programs and change efforts. Strategic thinker reputed for driving business goals while controlling costs and improving efficiencies that meet and exceed business goals.

Skills
  • Quality Assurance
  • Team Management & Mentorship
  • Budget and Cost Management
  • Regulatory Compliance
  • Manufacturing Processes
  • New Product Development
  • Process Flow Documentation & Organization
  • Scale Manufacturing & Validation
  • Design Verification & Validation
  • Medical & Electromechanical Product Development
Experience
11/2017 - CurrentCompany NameCity, State
Director of Quality Management & Engineering
  • Build and lead diverse team of 20+ Quality engineers, technicians and Quality system specialists in the production of diabetes management medical devices and allocate project resources based on analysis of project needs.
  • Communicate on behalf of Diabetes Care business unit to ensure specific needs are met in xx meetings with Multi-site Quality Directors group and relay information back to workforce and leadership.
  • Incorporate guidance in employee engagement, employee training and all projects developing digital health and infusion platform, as site lead for Andover office.
  • Scale manufacturing and validation processes to 100 million+ annual volume production.
  • Implement elements of Agile methodology to increase decision speed and accuracy by 30-50%, through connecting the right people to be present at the right times.
  • Lead change effort from outdated to upgraded software across business to drive efficiency and flexibility in QMS processes, resulting in creation of the first direct to consumer system capability.
  • Implement Post-market Surveillance Plan (PMS) through annual collaboration with medical affairs to create the Post-market Surveillance Report and Periodic Safety Update Report (PSUR) in preparation for transition from Medical Device Directive (MDD) to EU Medical Device Regulation (MDR).
02/2015 - 11/2017Company NameCity, State
Senior Managerof Quality Engineering
  • Manage Advanced Diabetes Care new product development quality team of 3-7 people, supporting up to 3 projects at time within mechanical, electrical and software fields.
  • Liaised with FDA, AAMI and Industry monthly to develop guidance documents, tools and processes for FDA's newly enacted Safety Assurance Case requirements.
  • Mentored 15-25 Junior and Senior-level Quality and R&D Engineers and Leaders, 60-70% were later promoted to higher positions.
07/2013 - 02/2015Company NameCity, State
Principal Quality Engineer
  • Developed the TPP (target product profile) , serving as contract guide for leadership and spearhead
  • Verified product requirements development, test method development/validations, design verification, design validation, supplier qualification and design transfer to manufacturer.
  • Created and maintained detailed QA project plan from development through launch to highlight cross-functional dependencies, exposing process ownership, accountability of tasks and expectation timeframes.
  • Provided quality engineering leadership for team of 7 within the combination electromechanical product development project to ensure customer expectations, regulatory requirements, appropriate industrial standards and BD policies/procedures were met.
  • Managed $5 Mil budget to implement ASR planning and execution, including Initiating metrology lab for production, research and development.
  • Spearhead all quality assurance areas including quality planning, risk management, electromechanical design assurance, manufacturing quality planning, and Design History File management.
02/2011 - 07/2013Company NameCity, State
V&V Engineering Manager
  • Verified product requirements development, test method development/validations, design verification, design validation, supplier qualification and design transfer to manufacturer.
  • Managed budgets as high as $300K, to ensure resource allocation and appropriate validation and verification of electromechanical and software products, consisting of +/-20 people globally.
  • Trained 5 junior engineers, 3 of which were promoted.
  • Lead team of 20 in designing electromechanical and software products, ensuring compliance with international standards (60601, 10993) , policies and procedures in 2011 as Team Lead before being promoted in 2013.
Education and Training
City, State
Masters of Science in Engineering ManagementPoint Park University
City, State
Masters of Science in Biomechanical EngineeringUniversity of Pittsburgh
City, State
Bachelors of Science in Biomedical EngineeringUniversity of Pittsburgh
Certifications

RAPS Regulatory Affairs Certificate (RAC)

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Resume Overview

School Attended

  • Point Park University
  • University of Pittsburgh

Job Titles Held:

  • Director of Quality Management & Engineering
  • Senior Manager of Quality Engineering
  • Principal Quality Engineer
  • V&V Engineering Manager

Degrees

  • Masters of Science in Engineering Management
    Masters of Science in Biomechanical Engineering
    Bachelors of Science in Biomedical Engineering

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