SUMMARY

• Accomplished Design Quality Engineer with over 15 years of advanced experience leading teams and executing projects across multiple industries and company sizes (including Fortune 500).
• Experience in quality planning activities to provide quality engineering support of product/process development for assigned products/areas.
• Provided leadership on championing departmental or cross - functional engineering initiatives and acts as an effective leader or team member in supporting quality disciplines, decisions and practices.

AREAS OF EXPERTISE

• Project Management
• QMS Complaint Management
• DHF compliance
• Internal and Customer Audits
• SDLC / STLC Management
• Corrective and Preventive Action
• Post Market Surveillance
• Risk Analysis & Mitigation
• 21 CFR Part 11 & EU Annex 11
• EU-MDR, Canadian Regulations
• Budget Management
• CFR 820 & 13485 Standards

TECHNICAL SKILLS

Operating Systems: Windows-10/7, XP, 2000, UNIX, Macintosh, DOS

Languages: MS-SQL, Java, .NET, C/C++, PHP Databases MS SQL Server, Oracle, DB2, SAP

Methodologies: SDLC, Agile, Waterfall

Testing Tools: QTP, Fitnesse, Silk Performer, Microsoft TFS

Tools: HP-QTP, Fitnesse, Microsoft TFS, DOORS, HP-Quality Center, Rational Clearcase, Rational ClearQuest, Windows-Azure, MS-Project, MS-Office (Word/Excel/PPT), MS-Visual Studio

PROFESSIONAL EXPERIENCE

Senior QA Consultant / Design Quality Engineer

Confidential, Iowa, Illinois

Responsibilities:

• Contract with Fortune 500 and other diverse clients to manage short- and long-term projects and assignments.
• Engage in QA systems and process implementation, process improvement and other related projects.
• Lead teams of up to 22 onshore and offshore resources while steering critical QA operations for projects.
• Oversee projects with total assessed values of ~$5M to $30M each ensuring fiduciarily sound management .
• Ensure compliance with regulations (i.e., cGDP, 21 CFR Part 11, EU Annex 11, CFR 820/ISO 13485).
• Independently engage in quality metrics and data analysis to ensure on-time and on-budget delivery of projects.
• Examples of key projects and related engagements are listed in the following examples.

Confidential

Sr. Design Quality Engineer

Responsibilities:

• Joined Eye Surgical Project team to execute strategic objectives and complete projects per specifications.
• Generate key project deliverables including requirements development, design review and V&V activities.
• Formulate Quality Management system for Confidential devices to ensure effectiveness, efficiency and compliance.
• Collaborate with R&D, IT, Clinical and Quality Assurance to improve adherence to regulations and procedures.

Confidential

Sr. Design Quality Engineer

Responsibilities:

• Worked cross-functionally with Sustaining Engineering and Manufacturing for enhanced project effectiveness.
• Collaborated with other groups to ensure safety and availability of remote cardiac monitoring medical devices .
• Worked on cross-functional teams to enhance understanding of product through inquiries and evaluation.
• Reduced complaint rates and provided support for troubleshooting operational issues and planned projects .

Confidential

Project Manager

Responsibilities:

• Worked with project team through end-to-end development lifecycle for social website using agile methodology.
• Participated in project estimating, planning and management activities to drive on time and on budget results.
• Supervised offshore team of developers, graphic designers, and marketers to complete the project on schedule.

Confidential

QA Lead

Responsibilities:

• Worked with customers and developers to design application changes that enhanced user experience.
• Engaged with project managers to ensure the system test plan was complete, consistent and accurate.
• Performed testing functions across multiple software products and coordinated UAT activities.
• Developed test scenarios, plans and requirement mapping to test cases and ensure accurate implementation.

Confidential

Sr. Principal Engineer

Responsibilities:

• Participated in key deliverables (i.e., requirements, design review, post market surveillance, and V&V).
• Provided subject matter expertise for the corporate Quality System and ensured training requirements were met.
• Formulated and recommended engineering policies and technical work in accordance with project objectives.
• Managed QMS Complaint Management system (Trackwise) to ensure effectiveness, efficiency and compliance.
• Collaborated with R&D, IT, Clinical and Quality Assurance to improve adherence to regulations.

Confidential

Sr. QA Analyst

Responsibilities:

• Joined Agile/Scrum team to focus on enhancing quality and engage in process improvement strategy.
• Spearheaded development of both automated and manual test procedures for a new Java web product.
• Interfaced extensively with product owners, developers, and internal/external stakeholders.
• Delivered quality strategy to maximize system efficiency, conformity, and accurate release schedule.

Confidential

QA Lead

Responsibilities:

• Developed the high-profile ‘SCT in the Cloud’ Project, utilizing Microsoft Windows-Azure.
• Prepared comprehensive plans and documents, coordinating functional and performance testing.
• Teamed with managers to evaluate performance, identify/implement solutions, and detect critical defects.
• Noted for skillfully translating product requirements and designs into clear test objectives.
• Provided critical input and guidance for Development Engineers, influencing future product roadmaps.
• Tested and released planning of iPad application to 700+ sales employees.
• Organized and directed User Acceptance Testing among 40 staff geographically dispersed across the U.S.
• Monitored project progress, identified/reported defects, and determined release cadence.
• Coordinated activities of UAT Team and drove on-time completion of testing (3 software releases in 3 months).

Confidential

Quality Test Manager

Responsibilities:

• Implemented new software product impacting 200+ employees and thousands of trainees/customers.
• Supervised and directed the work of 12-15 team members to deliver on-time project outcomes.
• Secured, setup, and maintained all test equipment, developing required software and automated system testing.
• Managed offshore team of 2 QA Testers in China, testing full lifecycle of full testing lifecycle for a $25M project.
• Wrote and reviewed test cases and documents (e.g., plans, design specifications, procedures, reports).
• Oversaw functional and regression testing of company’s expansive e-Commerce parts library web site.
• Earned reputation as trusted advisor, providing strategic guidance and recommendations for project roadmaps.