Director of Quality Management & Engineering Resume Example
Love this resume?Build Your Own Now
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
|
|
Experience
11/2017 - CurrentUltimate Kronos GroupJackson , MS
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- Lead change effort from outdated to upgraded software across business to drive efficiency and flexibility in QMS processes, resulting in creation of the first direct to consumer system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 - 11/2017Northrop GrummanBoise , ID
Senior Manager of 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 - 02/2015Becton Dickinson, Advanced Diabetes CareCity , 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 - 07/2013Philips Children's Medical VenturesCity , 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)
DISCLAIMER
Resumes, and other information uploaded or provided by the user, are considered User Content governed by our Terms & Conditions. As such, it is not owned by us, and it is the user who retains ownership over such content.
How this resume score could be improved?
Many factors go into creating a strong resume. Here are a few tweaks that could improve the score of this resume:
Resume Strength
- Word choice
- Measurable results
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
Similar Resumes
