Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Steve Krueger

Elm Grove,WI

Summary

Quality assurance and regulatory compliance expert with a proven track record in implementing quality initiatives for medical device organizations. Extensive experience collaborating with core teams to ensure successful product delivery in complex regulated markets. Strong focus on maintaining compliance and enhancing product quality through effective strategies and processes.

Overview

28
28
years of professional experience
1
1
Certification

Work History

Principal Consultant, Owner

MAK and Associates, LLC
12.2008 - Current
  • Managed company administration, professional networking, staffing, and consulting assignments.
  • Provided quality and regulatory compliance consulting for medical device companies.
  • Completed a risk-based approach to cost effective and efficient quality management system implementation to comply with ISO 13485, FDA QSR, MDD, CMDR, etc.
  • Developed and implemented regulatory and quality strategy and plans.
  • Completed 80+ quality system, process, product, and supplier audits.
  • Completed submission and resolution of medical device pre-market applications.
  • Served as subject matter expert for quality system management covering pre/post market activities including management review, internal auditing, CAPA, SCAR, NC, design review / transfer, complaint handling and device recalls.
  • Executed design controls development and remediation to enhance compliance standards.

Director, Quality Assurance and Regulatory Affairs. Management Representative

RF Technologies
11.2006 - 09.2009
  • Planned, implemented, and maintained company's Quality Management System (QMS).
  • Selected, mentored, and developed Quality and Regulatory Staff.
  • Verified and validated medical device and system software.
  • Implemented verification procedures for Microsoft service packs and security updates.
  • Managed departmental functions, including budgeting and resource allocation.
  • Directed product validation programs for quality test lab and manufacturing processes.
  • Appraised quality of contract manufacturers during in-process, installation, and service phases.
  • Developed prioritized international regulatory plan for market launch.

Manager, Production Support

Marshall and Swift / Boeckh
09.2005 - 11.2006
  • Managed production support department with 15 to 20 technicians and engineers, overseeing budget responsibilities.
  • Facilitated prompt resolution of product outages by analyzing issues and applying appropriate resources.
  • Reorganized production support group to enhance operating efficiency through continuous improvement initiatives.
  • Implemented ITIL processes for Release, Problem, and Incident management to standardize operations.
  • Reduced open production support work tickets by over 75% in second quarter of 2006, improving response times.
  • Enhanced customer satisfaction through systematic problem resolution and resource allocation strategies.

Director, Quality Assurance and Regulatory Affairs

Camtronics Medical Systems
09.2003 - 09.2005
  • Directed planning, organization, implementation, and management of quality assurance policies and programs.
  • Oversaw adherence to government compliance regulations and corporate policies across multiple departments.
  • Supported engineering, manufacturing, sales, service, and financial departments by implementing quality systems processes.
  • Identified key quality measures to drive continual improvement programs within the organization.
  • Facilitated daily leadership meetings to prioritize and resolve customer satisfaction and product quality issues.
  • Guided company through ISO re-certification for ISO 13485:2003 and CMDCAS quality systems certification.
  • Secured pre-market FDA approval for two major product launches successfully.
  • Led development of company's HIPAA program, including product requirements and disclosures.

Information Systems Consultant

Northwestern Mutual
05.2003 - 09.2003
  • Functional project manager and testing leader for company's field force automation application and services.
  • Responsible for the budget and management of contract site and offshore testing and development.
  • Led several concurrent development projects to an on time and on budget delivery.

Consultant, Verification and Validation Lead

Adecco Technical (GE Healthcare)
01.2003 - 05.2003
  • Provided functional consulting for system verification, system validation and software verification/validation.
  • Developed project test plans, project documentation, oversaw test execution, and compiled test results.
  • Led GEHC functional imaging testing for two new product introductions, two installed base releases, and a project to implement automated software and system testing.
  • Learned the functional and performance characteristics of CT and PET scanners.

Director, Cardiology Engineering Services

GE Medical Systems Information Technologies
01.2000 - 01.2002
  • Functional manager for a staff of thirty verification/validation engineers, system engineers, engineering technicians, service engineers, technical writers, and engineering interns.
  • Responsible for Cardiology Customer Centricity/Satisfaction and integration of GEMS customer escalation processes into the newly acquired Cardiology Modality.
  • Responsible for the serviceability and service readiness of over 1000 legacy and current products, including OEM contracts.
  • Responsible for the technical publication and documentation of all Cardiology products.
  • Maintained strong cross-functional relationships between engineering and QA/RA, engineering and service, and engineering and manufacturing.
  • Led the establishment of the engineering services group for the Cardiology business by successfully integrating the engineering services groups of three GE cardiology acquisitions to provide the business with seamless testing, documentation, product translations and engineering services.
  • Developed a serviceability project funnel that saved over 1.3 M in installing and servicing the Cardiology products.
  • Key contributor on a team that defined, implemented, and verified a global data collection system that enabled the company to track actual installation, warranty, DOA and service costs for our products. My contributions included collecting critical user needs, developing procedures to collect and process data, and defining/developing charts and reports.

Manager, Cardiology Validation Group

GE Healthcare
01.1999 - 01.2000
  • Responsible for product validation of cardiology product lines supporting HL7 interfaces, DICOM, image storage, and multiple cardiology modalities.
  • Responsible for the integration of Cardiology engineering group's validation policy and process into the GEMS product development process.
  • Functional manager responsible for validation lab management, people management, and budget management.
  • Led the successful validation of an integrated image storage solution that had a tight schedule and several customer commitments from an acquired company.

Systems Engineer

Marquette Medical Systems
01.1997 - 01.1999
  • Responsible for the integration of application software onto computer / network platforms which included requirements implementation, qualification testing, troubleshooting, and issue resolution.
  • Provided liaison support between sales/service and engineering team by handling escalated issues, pre-sales support calls, and product integration issues.
  • Led the integration of the product on the Windows NT networking platform through the development of technical documentation, manufacturing instructions, service instructions and sales support documentation.

Education

Bachelor of Science - Computer Science And Engineering

Milwaukee School of Engineering
Milwaukee, WI

New Leadership Course -

GE Medical Systems

Core Leadership Training -

GE AMC Crotonville

Six Sigma Green Belt and Black Belt Training -

GE Medical Systems

Skills

  • Leadership and change management
  • Analytical problem solving
  • Mentoring and training
  • Consultative advising
  • Data analysis and research
  • Negotiation skills
  • Quality management and control
  • Customer focus and engagement
  • Auditing and compliance expertise
  • Documentation review and management
  • Time management mastery

Certification

  • Green Belt
  • Functional Black Belt

Timeline

Principal Consultant, Owner

MAK and Associates, LLC
12.2008 - Current

Director, Quality Assurance and Regulatory Affairs. Management Representative

RF Technologies
11.2006 - 09.2009

Manager, Production Support

Marshall and Swift / Boeckh
09.2005 - 11.2006

Director, Quality Assurance and Regulatory Affairs

Camtronics Medical Systems
09.2003 - 09.2005

Information Systems Consultant

Northwestern Mutual
05.2003 - 09.2003

Consultant, Verification and Validation Lead

Adecco Technical (GE Healthcare)
01.2003 - 05.2003

Director, Cardiology Engineering Services

GE Medical Systems Information Technologies
01.2000 - 01.2002

Manager, Cardiology Validation Group

GE Healthcare
01.1999 - 01.2000

Systems Engineer

Marquette Medical Systems
01.1997 - 01.1999

Core Leadership Training -

GE AMC Crotonville

Six Sigma Green Belt and Black Belt Training -

GE Medical Systems

Bachelor of Science - Computer Science And Engineering

Milwaukee School of Engineering

New Leadership Course -

GE Medical Systems

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