Quality Assurance Supply Chain
Resume:
Debra Valiante
Wilmington, DE 19806
www.linkedin.com/in/debvaliante
June 14, 2012
Tunnell Consulting, Inc
King of Prussia, PA,
Dear Hiring Manager:
I was excited to find your ad for a manager of supplier quality. I am looking for a position offering me new opportunities and fresh challenges.
I am accustomed to working in a self-directed environment, yet equally comfortable working in a team environment. In my last position, I was liaison between suppliers and internal R&D, engineering, and manufacturing groups for development of new materials and resolution of supplier quality issues.
I have extensive experience driving supplier corrective and preventative action programs from initiation, to resolution, and through effectiveness verification.
I’ve implemented inspection and testing of materials to ensure conformity to specifications, as well as developed vendor specifications for new materials.
I’m accustomed to coordinating, participating in, and leading supplier audits and quarterly business reviews.
As you will see from my resume, my background and experience closely match those mentioned in the position description.
If you wish to contact me, I can be reached at 302-***-**** between noon and 8:00pm. I’ll be happy to hear from you.
Sincerely,
Debra Valiante
DEBRA VALIANTE
Wilmington, DE 19806 302-***-****
www.linkedin.com/in/debvaliante *****.*.********@*****.***
Summary
Technical Professional with extensive experience in the medical device industry. Proven ability to work independently and achieve results. Develops productive, effective relationships with co-workers, vendors, and across intra-company functions. Interacts well with individuals at all levels. Detail oriented and resourceful in completing projects. High degree of initiative; able to multi-task effectively: flexible to changing priorities; proven team player, leader, coach, and mentor. Lean Six Sigma Green Belt certified. Diverse background includes:
Packaging Design Supply Chain Management Quality Engineering
Supplier Qualification Project Management Quality Assurance
Supplier Audits Root Cause Analysis Technical Support
Professional Experience
SIEMENS HEALTHCARE DIAGNOSTICS, Newark, DE 1998-2012
Packaging Specialist, Strategic Procurement / Materials Management
Designed, developed, and qualified flexible packaging materials for use in medical devices and related consumable products. Managed and monitored supplier performance for quality, delivery, and relationship.
• Effectively managed upsets (raw material discontinuation, process equipment upsets, and natural disasters) to prevent and mitigate negative impact to supply chain.
• Developed, qualified, and provided technical support for flexible packaging (extrusion laminates, foils, thermoform films, blown films, labels, IFUs).
• Developed vendor specifications to ensure material compliance to requirements.
• Proactively worked with suppliers on cost savings and lean initiatives.
• Maximized efficiency by implementing lean manufacturing tools for material inspection and use.
• Contributed to achievement of global material strategies via written reports and formal documentation of qualifications and validations.
• Metric supplier quality performance, leading quality improvement and remediation programs as necessary.
• Qualified supplier auditor (ISO 13485:2003).
• Risk management assessment (FMEA) of new products, new materials, new or relocated vendors and processes.
• CAPA (Corrective and Preventive Action) investigation, resolution, and effectiveness verification of raw materials and end product customer complaints.
• Project leader for quality improvements of existing packaging films used in diagnostic consumables.
• Project leader for qualifications of new suppliers, new packaging design, alternate raw materials, equipment, and testing protocols.
• Project leader for validation of new supplier processes and materials.
Page 2 Debra Valiante
E.I. DUPONT DE NEMOURS, Newark, DE 1989-1998
Quality Technician; Quality Engineering and Quality Assurance, Medical Products
Protocol design for qualification projects and equipment validations. Review and release of diagnostic test products to meet quality standards.
• Internal auditor.
• Investigation and disposition of non-conforming products and raw materials.
• Responsible for maintenance of quality systems necessary to meet QSR and GMP.
OTHER RELATED EXPERIENCE
E.I. DUPONT DE NEMOURS, Newark, DE
Chemical Technician; Technical Support – Consumables Manufacturing, Medical Products
Provided technical support to consumables manufacturing for method chemistry via supplier interface, technical troubleshooting, and analytical lab work. Also provided technical support for physical pharmacy (tablets and blends) and liquid reagents used in the manufacture of diagnostic consumables, calibrators, and verifiers.
EDUCATION
University of Delaware, Newark, DE – Credits Completed 61
Delaware Technical & Community College, Stanton - Newark, DE – Credits completed 48
Professional Development / technical Training
• Practical Experimental Design and Data Analysis; University of Delaware, Division of Continuing Education, Newark, DE
• Problem Solving and Root Cause Training; Dade Behring, Newark, DE
• Basics of Supply Chain Management; Del Tech / Dade Behring, Newark, DE
CERTIFICATIONS AND LICENSES
• Lean Six Sigma Green Belt Certification: Delaware Manufacturing Extension Partnership
• Lead Auditor Training: Dade Behring Corporate Compliance
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