Summary of Expertise
• ASQ Certified SIX SIGMA BLACK BELT
• ITIL Certified
• MBA (Marketing Research & Finance)
• Extensive experience implementing process improvement initiatives across entire SDLC using CMMI methodologies.
• Experience in implementing Six Sigma tools and strategies for process improvement.
• Hands on experience providing software test engineering, as well as, software process improvement for a diverse arena of software projects.
• Experienced in Auditing Software project from Project initiation to project closure.
• Experienced in implementing metrics program in project life cycle.
• Possesses excellent communications and interpersonal skills.
• Expert in FDA design control guidelines for medical device.
• Extensive experience in performing Risk Management activities in compliance with ISO 14971
• Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485
• Experience in implementation of company policies and procedures to ensure compliance to applicable regulatory agencies.
• Expert in applying advanced Quality Tools and facilitate coaching and training on application of tools such as DOE, Advanced Statistical Techniques, QFD, Weibull, CTQ etc.
• Extensive experience in leading cross functional project teams for issue investigation/root cause analysis and resolution process to meet regulatory requirements and business goals.
• Utilize Design for Six Sigma methodology/tools to promote a disciplined approach to product and process design.
Process and Procedures
• Improved product quality and reliability through implementation of industry best practices like CMMI, Six Sigma and Lean.
• An highly accomplished Quality Management Personnel with 10 years comprehensive experience in effectively “initiating”, “diagnosing”, “establishing”, “implementing” and “assessing” Quality process improvements.
• CMMI, Lean and Six Sigma process improvement model expert.
• Multiple industries – IT, Banking, Automotive and Healthcare, Medical Device.
Principle Design Assurance Engineer (Six Sigma Black Belt) July 08 – Present
St. Jude Medical – Implantable Electronic Systems Division
Sylmar – California.
• Lead Six Sigma Process Improvement project for service center engineering to help them reduce cost of repair, improve quality, and reduce cycle time for repair by deploying new processes and standards across the department.
o Improvements :
Cycle time for repair of transmitters reduced by 54%
Cycle time for repair of Programmers reduced by 36%
Improved the analysis process of programmers and transmitters and reduced the no defects found units by 80%
Reduce the number of returns by more than 50%
• Lead projects that improved customer satisfaction in terms of reducing cycle time, reducing rework and re-engineering of business processes to reduce non value added activities
• Monitor Audits for FDA design Controls and provide feedback to the leadership, provide recommendations.
• Confirm and document traceability between objective evidence documentation and EN IEC 60601-1 standard requirements and all relevant standards.
• Manage continuous improvement activities regarding quality of all products.
• Evaluate field performance of products by reviewing field data, supporting technicians to evaluate unusual returns and supporting Technical Services in responding to customers.
• Mentor Green Belts and Black Belts on continuous improvement projects.
• Chair the Corrective and Preventive Action Board for St. Jude Medical and track corrective action projects for closure in compliance with FDA guidelines.
• As a design assurance lead, heading a 450 M project on next generation programmer as a design assurance lead.
Involved in supplier selection process and providing inputs to the team in term of current sustaining field issues to make sure appropriate steps are taken to mitigate the current field issues.
Involved in Usability engineering in compliance with IEC 60601-1-1 standard
Providing guidance to the team on designing of the new programmer to make sure its compliance with IEC 60601-1 3rd edition.
Providing feedback to the team on sustaining field issues and taking appropriate steps to make sure new product meets a high standard of quality.
• Risk Management: Provide Risk Management strategy for the design and development of new products in compliance with ISO 14971 and IEC 60601-1 3rd edition
• Serve as a board member of the compliance committee
• Serve as Design Assurance Lead on software projects that are submitted to FDA, TUV and Canada, and oversee all design assurance activities like, Risk Management, FDA Audits, and compliance to standards like IEC 60601-1, IEC 62304, and IEC 80001. Work with Verification group and field issues group on all quality related issues and provide a mitigation plan for the same.
• Work with leadership team of different functional areas of the company to provide guidance on process improvement projects and provide Six Sigma mentoring on identified projects.
• Metrics: Create comprehensive reporting and analysis by extracting data from multiple source systems, including Data Warehouse. Lead team in reporting metrics to leadership team and critically inspect results.
Process Improvement Manager (PMO): Oct 05 – Jul 08
Kaiser Permanente – Pasadena – CALIFORNIA USA
Project: SLCI (Solution Life Cycle Initiative)
The Solution Life Cycle Initiative (SLCI) targets enterprise-wide improvements in solution delivery processes and tools for requirements-gathering, estimating, testing, design, reuse, life cycle change management and lifecycle metrics. It is also part of the Business Engagement (BE) Organizational Effectiveness initiative, which aims to provide an end-to-end solution methodology to improve KP-IT’s way of engaging business partners.
• Support areas include project planning, project monitoring and control, metrics; risk management, issue and change control management; quality and process implementation.
• Status & Metrics - Review metrics that are published from the PMO Status and Metrics team members, provide updates to the leadership. Assist team with team-level metric definition and analysis.
• Assist in facilitating Scope Management, including impact assessments.
• Support internal project communication between the PMO and various SLCI tracks.
• Support lessons learned activity for the group.
• Create and track project management plan, work plan, milestones, deliverables, and budget.
• Provide advice on governance of projects and ensure compliance with relevant standards
• Defined and implemented integrated progress reporting framework
• As a Six Sigma Black B...
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