PROFILE
RESULT-ORIENTED MANAGER with experience in quality, process & development in high tech, international industries.
Proven success as technical interface across multiple organizations ensuring products / processes reflects business goals.
Strength in leading teams using quantitative methods / tools for effective analysis & problem correction (DMAIC, DOE, VSM, RCA).
Recognized to drive and motivate team members resulting in efficiency increase and enhanced strategic goals / objectives.
- Quality Management
- Auditing
- Customer Relations
- Root Cause / Corrective Action
- Regulatory Compliance
- Continuous Improvement
- Program / Project Management
- Technical Training
- Strategic Planning
HIGHLIGHTS
PERFORMANCE AND RESOURCE MANAGEMENT
- Developed, implemented and maintained Global Quality Management System (QMS); led a cross-departmental team (250 employees) in creation / modification of the system and obtaining ISO 9001:2008 certification. Key QMS owner addressing quality issues, continuous improvement & ensure alignment.
- Customer representative to address quality complaints, monitored metrics and provided clear concise expeditious response that resulted in improved customer relations.
- Interfaced with customers ensuring conformance as Lead Auditor / liaison for customer audits and survey requests. Addressed findings (closed-looped corrective actions), concerns, & negotiated resolutions resulting in $31M additional revenue.
- Successfully managed, global implementation of Agile; Product Quality Module (virtual and in person), for Global close looped CAPA and audits. Included structure identification, procedure / instruction creation and global training resulting in 35% decrease of CAPA closure rate.
- Led a multi-organizational audit team to ensure adherence to process methodologies. Received Vice President’s Priority Award.
- Established quality plans, procedures & incorporate into manufacturing by cross departmental interfacing.
- Established and compiled organizational metrics for submittal to customer per contractual requirements, resulting in consistent format of metrics delivered per contractual schedule.
- Ensured process compliance, utilizing experience with ISO9001, AS9100 & Class III medical devices.
- Staffed / managed 45 quality members, ensuring product quality standards integrity & compliance.
- Managed Technical Training department. Created training material (Instructor & computer-based), deployed to 1300 local & worldwide personnel. Developed / led audits for validation of training and drive improvement.
- Team-member of Long Range Capacity Planning Work Group that developed accurate model to forecast equipment and head-count requirements. Key contributor identifying current model / actual gap. Received Spontaneous Recognition Award for innovativeness and contributions.
QUALITY
- Developed manufacturing operational excellence through application of Six Sigma Initiatives (SPC, Root Cause [Pareto / Fish bone] analysis, 8D corrective action).
- Utilized Six Sigma Green Belt (DMAIC) training for manufacturing project, resulting in $120K / yr savings.
- Supported Lean Manufacturing & 5S programs, resulting in organized, safe and efficient production area.
- Main technical interface between supplier, quality & purchasing ensuring material availability and quality.
- Guaranteed process control, traceability, change notices and SPC methods reflected company’s focus.
- Identified improvement Quality system. Facilitated implementation (local / global sites) worked with functional management to document changes in accordance with company, regulating agencies & customer requirements.
- Interfaced across functional areas / departments to resolve process issues, containment, and determine root cause. Developed and implemented effective Corrective and Preventative Action (CAPA / FRACAS).
- Redefined Material Review Board (MRB) requirements, including specification update and creation of electronic training. Successfully led team through customer probationary MRB process and authority.
- Ensured assembly drawings, test documentation and inspection work instructions for proper incorporation of workmanship standards and inspection requirements for in process, first article and final products.
- Established key quality indicators for process control & implemented visual management.
MANUFACTURING
- Project leader for installation and qualification of manufacturing equipment and bulk chemical delivery system. Interfaced across several internal and supplier areas to ensure project completion, all documentation and training performed within the defined scope / time of the project, resulting in an estimated $10K / yr chemical reduction and increased safety.
- Utilized Value Stream mapping identifying areas of improvement, resulting in 13% process improvement.
- Optimized manufacturing processes for linkage to goals. Facilitated implementation to ensure integration throughout organization.
- Team member of Task Force to determine reliability failures due to stress cracks of Intel’s next gen microprocessors (‘Core 2 Duo’) prior to product launch. Root cause determined, yield increased from 97% to 99.88%, resulting in $12M annual savings. Received ATD Achievement Award.
- Applied designed experiments (DOE) to de...
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