SUMMARY:

• Results driven quality professional with strong business and leadership experience focused on execution, accountability and results. Lean Six Sigma Master Black Belt/Black Belt and Project Management Professional experienced in quality methods, continuous improvement, strategy deployment, and transforming cross - functional operational and transactional environments. Highly skilled in quality assurance and quality control, new business due diligence, merger and acquisition, project management, team facilitation, curriculum design, and delivery. Vendor relations and supply chain management.
• Certified Six Sigma Black Belt/Master Black Belt · Certified Project Management Professional
• Lean Master · ISO 9001, TL9000, AS9100, ISO 13485 QMS · IEC 60601 · Change Leadership · Transactional Operational/Process Excellence Operations/Production Management ·
• Business Process Re-Engineering Performance Improvement · Curriculum Design · Delivery
• Coach/Mentor · Internal Consultant · Lean/Kaizen Events · Business Process Auditor
• Root Cause Analysis & 8D Problem Solving · Quality Engineering · Standard Operating Processes

TECHNICAL SKILLS:

Computer Skills: MS Office Suite, Minitab, MS Project, MS Project Server, Visio, DocuShare, SharePoint

PROFESSIONAL EXPERIENCE:

Confidential

Vendor Relationship Manager

Responsibilities:

• Manager of several direct reports in the day to day operations of supplier management, quality assurance and quality control in a growing fast paced medical part distribution environment. Created and implemented the initial supplier qualification criteria and the ongoing supplier performance monitoring processes.
• Delivered root cause and customer complaint handling modules to other staff members. Coach train and mentor quality staff in supply chain management techniques and methods including: new supplier approvals, initial and ongoing supplier surveys, new supplier part reviews and approval including first article inspection and color and master sample control, supplier corrective actions (SCAR's), supplier communication, supplier audits, supplier drawing and part specification control, review of supplier generated Conflict Mineral, Reach and RoHS letters of compliance and test reports.. Managed the resolution of customer complaints for part and material issues.

Confidential

Senior Manager, Quality

Responsibilities:

• Developed monthly operations metrics. Manage the post market surveillance process. Manage the customer returns, repairs and failure analysis process. Participate in design review meetings providing feedback on quality, risk mitigation plans and compliance UL safety standards for new and modified products. Project Lead for new veterinary product. Developed and initiated a new Verification and Validation test protocols and reports for product and manufacturing processes. Developed and initiated new first article inspection process similar to AS9120. Managed the creation and standardization of: design history files, device master records, device history files and technical files. Submitted amendments to: the Health Canada medical device list and EU MDD product list. Submit product to UL for safety testing and classification to IEC60601-1, UL and CSA standards. Submitted requests for product testing to: TUV for IEC 60601-1 3rd edition testing.
• Managed 22 operations and manufacturing team members from May thru October 2011.Managed and developed the purchasing and supplier management process, including purchase order approval, supplier qualification, RMA’s, and billing discrepancies etc. Develop supplier contracts for distribution, manufacturing, consulting and quality. Conduct assessments of new suppliers operations and capability to deliver on contract requirements with the potential to become take-over targets. Conducted due diligence assessment on a merger and acquisition company’s quality management system, FDA compliance to 21 CFR Part 820 and product repair reliability. Coach, train and mentor quality and operations staff in continual improvement techniques such as Lean, 5S, load leveling, visual management, TPM, kaizen and FMEA etc. Project manager for the warehouse re-design project, test lab creation, SOP Standardization
• Assembly line lean layout, machine shop 5S, the marketing sales show process creation and demo inventory management projects. Project manager for: prep for two hurricane, remediation, rebuilding and expedited facility move management. Managed product recall for domestic and international customers. Managed recall supplier. New business integration planning and merger management.

Confidential

Quality Assurance Engineer Senior

Responsibilities:

• The leading international aerospace supplier of hi-tech electronic devices supplying military, aerospace and commercial customers with cost effective, high reliability COTS/MOTS products.
• Interact with manufacturing and engineering departments to generate failure analysis reports for customer returns.
• Lead the Process improvement steering committee member responsible for selecting and authorizing projects.
• Modified and improved the idea hopper for projects including the identification of Six Sigma and Lean Methodologies. Trained 25 staff members on Lean techniques. Facilitated several improvement projects for variation reduction, waste elimination and work flow improvement. Managed several process improvement projects using Lean, Workout and project management methodologies. Projects included automation of corrective action process in SQL server environment, re-engineering of the internal audit process and failure analysis process. Combined project savings $60,000. Mentored, coached and trained less senior QA engineers in internal auditing techniques. Implemented new approaches to solving problems in DDC identified during quality assurance activities. Managed project to upgrade to new revision of Mil-Prf. 38534 for Hybrid Electronic manufacturing. Establish and maintain quality planning procedures and the AS9100 certified system. Perform internal and supplier audits to AS9100 standard. Worked with purchasing to update supplier management guidelines including performance reporting. Updated Supplier Quality clause requirements and rewrote the supplier management procedure.

Confidential

Master Black Belt

Responsibilities:

• Managed several Lean projects in operations and transactional groups including reducing demerge charges related to late third party inspectors, 5S in refinery maintenance areas, Workouts (Kaizen events) in accounting department, Value Stream Mapping and process transformation plans in GPE department. Coach and mentored seven new green belts in Six Sigma and Lean tools and methodologies. Project savings $300k. Instructed over 15 courses of Lean and Project Management and trained over 125 employees. Team member on $250mm P3M (project, portfolio and program) system implementation. Responsibilities included selecting reviewing, approving and monitoring the performance of external contracted instructors for Lean, Six Sigma, and Project Management.

Confidential

Corporate Six Sigma Manager

Responsibilities:

• Global leader in electrical and electronic wiring devices lighting energy management solutions and commercial data infrastructure products.
• Conducted audit of a major suppliers China facility and identified continual improvement opportunities. Black Belt lead on cash application project with corporate finance. Black Belt lead on a manufacturing six sigma project in the North Carolina facilities for cycle time improvement and cost reductions. Leveraged savings from Six Sigma projects across the operations in the US, Mexico and China. Corporate oversight of 22 sites UL ISO 9001 registrations. Assisted corporate packaging design group in achieving their ISO9001 . Created and delivered Six Sigma . Audited mainland China facility. Assisted Rhode Island Distribution facility with improvement projects.

Confidential

Lead Auditor

Responsibilities:

• Participated in a lean value stream mapping project savings - reduced the cycle time to issue s to customers from two months to less than two weeks. General Managers in 2003 for contributions that helped increase the business. Managed a team of 10 Customer Service Representatives.