Supporting injection molding.

Responsible for entire quality system and all quality personnel. Quality representative for the company.- Led quality team consisting of Quality Engineering, Document Control, and Quality Inspectors.- Interfaced with customers to ensure all of their quality needs were met by MME.- Established daily MRB to ensure quality issues were being addressed quickly.

Responsible for the quality of products and ensuring procedures meet regulatory requirements• Point of contact for product safety audits, ensuring products continue to be certified to ISO 60601• Provided leadership for quality system improvements, resulting in process improvements while continuing to be compliant to regulations• Addressed CAPA’s, resulting in identifying root cause and taking actions to eliminate that cause• Site Quality Representative, providing leadership for multiple successful external audits• Employee Engagement Leader, coordinating many years of successful site events

Responsible for the quality of products and ensuring procedures meet regulatory requirements• Point of contact for product safety audits, ensuring products continue to be certified to ISO 60601• Provided leadership for quality system improvements, resulting in process improvements while continuing to be compliant to regulations• Addressed CAPA’s, resulting in identifying root cause and taking actions to eliminate that cause• Submitted change orders to address documentation issues due to the product transfer from Rockland, MA, ensuring the documentation correctly represents the product and product is manufactured to proper specifications• Site Quality Representative, provided leadership for multiple successful external audits• Employee Engagement Leader, coordinating many years of successful site events• North American Smiths Medical Ambassador Co-Chair, leading fellow Ambassadors to improve company culture and drive company initiatives

Responsible for the quality of products and ensuring procedures meet regulatory requirements• Facilitated the creation of process and product risk assessment plans (FMECA), resulting in a clear understanding of the potential impact of process steps or product specifications on the customer and plans to mitigate any unacceptable failure levels• Investigated and responded to customer complaints, providing a clear understanding of any product issues• Investigated and responded to nonconforming material issues, resulting in the identification of the root cause and the implementation of corrective actions• Created and executed qualification plans for new product designs, ensuring that materials provided by suppliers would continue to meet the design specifications and function properly

Responsible for the quality of products and responding to customer complaints, as well as improving the overall quality system• Led quality group to ensure materials (2 Incoming Inspectors) and products (4 Final Inspectors) met customer quality expectations, resulting in continually providing a high quality product to our customers• Created and executed Manufacturing and Order Entry Validation Protocols prior to the launch of new products, resulting in the identification of any potential manufacturing issues prior to the launch of new products• Created standardized metrics, identifying significant quality issues and opportunities for improving products, as well as understanding the effectiveness of completed improvement projects• Conducted Monthly Quality Review Meetings with senior management, ensuring the key quality measures were reviewed and any product issues were being addressed• Facilitated customer complaint team, resulting in quick and effective responses to customer issues

Operations Supervisor (2006 to 2007)Responsible for meeting customer demand for products while managing costs• Provided leadership to three production lines (24 direct reports) with high growth rates and continued to meet sales needs, resulting in consistently exceeding quarterly revenue targetsManufacturing Quality Engineer (2005-2006)Responsible for continuous improvement of manufacturing and supplier quality through analysis of defect data, root cause analysis, and establishing corrective actions• Provided leadership for Lean Manufacturing initiative, developing process flow maps which clearly identified the work for each operator, resulting in a successful implementation• Created process for the development of Manufacturing Quality Control Plans, resulting in a clear method for linking design specifications to the manufacturing procedure for a product• Facilitated the creation of FMEAs, resulting in a clear outline of the potential issues that products might incur and the steps in place to mitigate those issues• Facilitated several root cause analysis exercises, expediting the identification of the true root cause, resulting in reducing cost to investigate the issues and more immediate resolution of the issues

Manufacturing/Supplier Quality Engineer (2003-2005)Responsible for continuous improvement of manufacturing and supplier quality through analysis of defect data, root cause analysis, and establishing corrective actions• Led cross-functional and cross-site team, reducing issues during customer installations with potential annual savings of $300,000. Presented project status to upper management• Completed Six Sigma Black Belt Certification Project, improving quality in Japan and resulting in $150,000 in annual operational savings and $1.3 million in inventory savings• Led Management By Fact (MBF) efforts with suppliers, improving their quality and resulting in a 52% reduction of defective parts received by Eastman Kodak• Developed annual strategies for the Manufacturing Quality group, defining group goals and providing tactical direction for achieving those goals• Participated in several Lean Manufacturing Kaizen Events, resulting in up to 80% reductions in walking, production floor space, touch time, and machine travel distanceManufacturing Engineer (2000-2003)Responsible for ensuring the production line ran smoothly by responding quickly to defects and obsolete parts, dispositioning of nonconforming material, incorporating new design changes, and updating Standard Work Procedures• Served as Manufacturing Representative on the cross-functional Product Data Management Steering Committee, ensuring manufacturing’s needs were being met by the PDM system• Coordinated rework of obsolete memory boards, resulting in savings of $100,000 in material costDocument Control Coordinator (1999-2000)Coordinated the creation and revision of Standard Operating Procedures; ensured any revisions to procedures or forms maintained the integrity of the plants quality system• Asked to take interim Document Control Coordinator position, ensuring the manufacturing plant remained in compliance with ISO standards and FDA regulations