Medical Device Quality System Consultant Specializing in FDA QSR, ISO 13485 and ISO 9001

Technical Consultant #1593


  • FDA and ISO compliance, particularly for medical devices and related software systems.
  • Quality system auditing.
  • Supplier quality assurance, audits and FDA checks compliance.
  • Software verification and validation.
  • Software project management.
  • Process assessments and improvement.
  • Computerized systems validation.
  • Software risk management.
  • Software life cycle documentation.
  • Quality system training.


Independent Consultant

Abbott Laboratories Diagnostic Division, Irving, TX, 1986 - 2009

Manager, Division Software Quality Assurance and Validation, 1996 - 2009

  • Provide and ensure Laboratories Diagnostic Division (ADD) software based medical device products were safe, effective and compliant with internal and external quality and regulatory standards.
  • Conducted numerous quality system and product assessments. Led multiple process improvement initiatives through successful implementation.
  • Developed a product defect and customer complaint resolution process utilizing quality management tools (Six Sigma DMAIC, fish bone diagrams, process flow diagrams).
  • Developed and conducted Quality System training for internal and supplier based project teams.
  • Training included FDA QSR, 21CFR Part 11, Design Control and good software engineering practices.
  • Led the development and validation of quality system software. Created specifications, project and test plans, design documentation, test protocols and validation summaries.
  • Established software development, validation and quality assurance processes for ensuring product quality and reliability in accordance with FDA QSR, ISO 13485, 9001, 9000-3 and 12207 requirements.
  • Established a Divisional Software Supplier QA function responsible for assessing medical device and software supplier compliance to industry and regulatory standards.
  • Conducted OEM supplier audits (FDA QSR & ISO 13485) and managed corrective and preventive action plans through completion. Reduced defects in delivered software based products by 50%.
  • Successfully defended Diagnostics software products during FDA and ISO compliance audits, avoiding FDA observations and maintaining ISO certification.
  • Represented Laboratories on external software and medical device standards committees, helping define requirements and best practices for medical device software.
  • Established and led a process focused Software QA organization, successfully implementing the SQA function across multiple sites in the United States. Significantly reduced software development cycle times and defects.
  • Led a team of senior software managers in defining and implementing a Divisional Software.
  • Development process for medical device software that complies with FDA and ISO regulations.
  • Led the implementation of a divisional non-product software life cycle process with the goal of reducing cycle time.
  • Led a team of senior IT professionals in the assessment and remediation of computerized systems for compliance to FDA 21CFR Part 11. Established system level requirements to ensure consistent and sustained compliance.
  • Developed FDA 510k medical device software submissions, resulting in successful product launches and updates.
  • Spearheaded a site Validation Review Board, chartered with providing expert oversight into all regulated software projects. The VRB oversight enabled consistent application of process and reduced project cycle times.

Lead Software Engineer/Software Quality Assurance Engineer, 1986 - 1995

  • Designed and developed real-time embedded software for a therapeutic drug monitoring analyzer.
  • Developed and presented a high volume abused drug detection system to the United States Department of Defense. Installed and ran computer systems during on site evaluation. Conducted site inspections to ensure successful system installation.
  • Defined and implemented diagnostics software metrics program, which led to a significant reduction in emergency software releases due to escaping software defects.
  • Directed the investigation of product related customer complaints for software based products in accordance with ISO and FDA regulations.
  • Developed system level validation plans and protocols for both internally and externally developed laboratory management systems.
  • Contributed to successful ISO 9001 and 9000-3/TicKIT certifications for the site.

Honors & Publications

Academic and Professional Affiliations

  • Member AAMI Medical Device Software Committee
  • Member American Society of Quality (ASQ)


  • RABQSA ISO 9001/13485 Quality System Lead Auditor
  • ASQ Certified Software Quality Engineer (CSQE)


  • Presented papers on software validation and process simplification at medical device software conferences and seminars.


  • B.S. Computer Science, Northern Illinois University, DeKalb, IL
Save Resume #1593
to Contact Form?

You must first click "Yes" to save this resume

Submit Request

Links to Other Candidates:

Life Sciences Compliance Consultant Specializing in Quality ...

Medical Device Expert for Quality Assurance and Regulatory ...

Medical Device Quality Management, Compliance, and Engineering ...

You have no Saved Resumes

Add resumes within our various Ares of Expertise by clicking "Add Resume(s)" below.

Add Resume(s)