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

Expertise

• 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.

Experience

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)

Credentials

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

Publications

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

Education

• B.S. Computer Science, Northern Illinois University, DeKalb, IL