Quality Engineer Manager

DAVID LANTZ

Lebanon, PA ***** ****.*****@*******.***

717-***-**** linkedin.com/in/davelantz/

Manager, Quality Systems

Quality Professional with verifiable experience seeking a challenging role. Self-starter who is driven to create positive results. Demonstrated ability to manage multiple teams and projects globally. Proven negotiator and organizer capable of resolving complex issues.

•Industry experience includes Healthcare, Defense, Automation, and Manufacturing

•Design Controls Subject Matter Expert - Quality Management System content creator, editor and trainer

•Corporate QRM Track Lead for Product Controllership / Universal Device Identifier project

•2013 GE Healthcare IT CEO Award Winner

•Professionally certified software quality engineer, auditor, medical device auditor, and scrum master.

SKILLS

QMS Design Controls Subject Matter Expert

Senior level adviser on Design Controls issues and questions.

Certified QMS Lead Auditor

Project Management NPI and Design Change

25+ years’ experience in project management.

Design Process Simplification, Lean Transformation & Change Acceleration Process

Trained in GE CAP and Lean methodologies.

QMS Educational Development and Training

Developed and delivered both online and instructor led training.

CAPA and Recall Prevention Investigation and Mitigation

WORK EXPERIENCE

GE Healthcare Digital Aug 2007 – Dec 2019

Quality Program Manager

Quality Engineer Program Manager for multiple medical device software teams. Managed all aspects of design controls for NPI and design change projects from inception through design transfer including risk and defect management, system validation and project metrics.

•Managed 6 project teams consisting of approximately 185 engineering personnel across the globe.

•Design Controls SME responsible for creating, evaluating, editing, and training on the QMS in an ever changing regulatory and business environment – ISO13485-2016 and MDR

•Authored “Software Lifecycle and US FDA Guidance” presented at US-China Medical Device Software Workshop in 2011

•QMS process simplification - drove reduced process lead times and approval cycles for QMS evidence by 33%

•QRM Track Lead for a $20M+ multi-discipline, multi-year Product Controllership / UDI project that improved GE's product management and commercialization

•CAPA Review Board - CAPA investigations and remediation along with Recall Prevention analysis and implementation including DFMEA, Risk Analysis, and Root Cause Analysis

•Design Controls Internal Auditor; conducted 2-3 design controls audits per year for internal and external customers

•2013 Healthcare IT CEO Award Winner for organizing and managing a defect management cross-discipline team effort that reduced the defect backlog 65%

DAVID LANTZ ****.*****@*******.*** Page Two

Penn Homeland Ventures, LLC Sep 2002 – Dec 2011

Owner Operator

Owned and operated a dental equipment service franchise

Purchased start-up franchise and developed Central Pennsylvania market with over 200 customers

Responsible for all aspects of the business including marketing, customer relations, technical services, and delivery

ADDITIONAL RELEVANT EXPERIENCE

Profitkey International

Director, Business Development

Made2Manage Systems, Inc.

Manager, Business Partner Services

CIMNET, Inc.

Product Manager

PRL Industries, Inc.

Chief Engineer

Textron Lycoming, Inc.

Advanced Quality Engineer

Carl Zeiss, Inc.

Project Engineer

EDUCATION

Bachelor of Science, Mechanical Engineering

Lehigh University, Bethlehem, PA

Kappa Alpha Society

CERTIFICATIONS

JUN 2022 – Certified Software Quality Engineer – ASQ

JUN 2022 – Certified Quality Auditor - ASQ

Certified ISO 13485 Lead Auditor – Caliso Consulting

Certified Scrum Master – Scrum Alliance

INTERESTS

Odyssey of the Mind

Coach, State Judge, Regional Problem Captain, Regional Awards Chair

Odyssey of the Mind is a creative problem solving competition for kindergarten through college age students to teach and foster creative/critical thinking

Students are presented with different long term and spontaneous problems which they solve through creative/critical cooperative thinking

Competitions are held at the regional, state, and world levels

A truly worldwide competition with the World Finals seeing 15,000+ participants on 890+ teams from 15+ different countries

Contact this candidate