SUMMARY

• Broad Knowledge of manufacturing processes including electronics (PCB design, PCB manufacturing methods, loading, soldering, testing) and micro - electronics (hybrid circuits / assembly / testing / inspection / failure analysis.), and metals (forging / foundry / fabrication / welding / machining)
• More than ten years of biomedical Quality Engineering experience, including medical devices such as trauma / reconstructive implants, implantable drug pumps, pacemakers, patient monitoring systems, MRI and CT scanners, “smart” hospital beds, portable ambulance equipment, and automated medical test lab equipment. Experienced in teh remediation of medical device CAPA, Complaints, and Supplier / Purchasing Controls.
• Experienced in both destructive and non-destructive test methods and post-test data analysis in support of New Product Development and production. Developed electronic, electro-mechanical, and environmental process and product validation protocols for overseas suppliers of automotive and consumer products.
• More than ten years of automotive / truck parts manufacturing experience, including supplier quality management, development of FMEA (comparable to ISO 14971), measurement systems, document control, internal auditing, corrective / preventive action, and continuous improvement functions.
• Reduced supplier quality costs by 50% at supplier of automotive audio systems manufacturer through aggressive Supplier Quality process, including use of teh PPAP Process, creation of a Supplier Handbook, improved incoming test protocols, and Implementation of supplier audits wif follow-up corrective actions.
• A former Supplier Quality Manager who trained suppliers in methods for Advanced Quality Planning including PPAP / APQP / FMEA and Statistical Methods (Control plans, sampling plans, design of experiments).
• Authored numerous quality policies, manuals, quality system procedures, test protocols, and work instructions, using distribution methods such as desktop publishing, and intranet sharing.
• Represented my employers to global suppliers in teh US, Europe, and Asia through independent initiative and exercise of corporate goals.
• Experienced in teh areas of budgeting, quality cost analysis, quality planning, and project management.
• Developed, implemented, and maintained quality management systems supporting Ford Q101/Q1 ISO 9000:2008, QS-9000, ISO-14001, AAR M-1003, GMP (medical devices), and ISO/TS 16949 Quality System Requirements using a Project Management approach.
• Reporting to Thyssen-Krupp-Gerlach CEO, successfully developed and maintained a multi-state implementation of a QS-9000 / ISO 9001 Quality System which also achieved Ford Q1, Chrysler Pentastar, and GM recognition. dis registration brought in millions of dollars in new business.
• Managed 3rd party ISO-9000 and QS-9000 regulatory body compliance and certification audits as employer’s “Management Representative”.
• Maintained all required Quality System functions (Document Control, Internal Audit, Corrective and Preventive Action, Continuous Improvement, Customer Satisfaction) for Quality System registration.
• Provided leadership and direction to as many as 30 associates, including professionals such as technicians, engineers, and metallurgists through management of multiple high-visibility corporate projects.
• As Lead Auditor, set up and conducted internal Quality System gap audits and external supplier qualification surveys to ensure compliance wif regulatory body requirements.
• Certified as an Instructor for teh Ford Global 8D® Structured Problem Solving System training approach. Trained and facilitated Structured Problem Solving Teams using teh Ford 8D® system for root cause and risk analysis and development of corrective action plans.

TECHNICAL SKILLS

• Microsoft Windows (XP/2000/NT/Windows 7)
• Microsoft Office including Word
• Excel
• Access
• PowerPoint
• MS Project
• Visio
• Publisher
• WordPerfect (conversions)
• Adobe Acrobat Pro
• intranet web site design
• word processing
• video editing
• information systems design
• database design and administration using MS Access
• Visual Basic
• SQL Server
• financial management
• project management
• graphic / document design
• and preparation of internal/external correspondence
• reports
• procedures
• test protocols
• manuals
• presentations

PROFESSIONAL EXPERIENCE

Confidential, Dover, OH

Senior Quality Engineer

Responsibilities:

• As a member of teh Complaints and Repairs work-streams, developed and field tested a system for coding causes for products being returned wif alleged defects and teh resulting decisions in teh repair area (to repair teh product, to return, or to scrap).
• Developed Quality System integration/remediation documentation to bring teh Quality System of a newly acquired medical device manufacturer into alignment wif teh corresponding system element at Confidential

Confidential, Warsaw, IN

Senior Quality Engineer

Responsibilities:

• As Team Leader assigned to teh Closed CAPA Remediation Project work stream segment of teh Confidential Project, successfully met all deliverables goals for Confidential ’s response to FDA 483 letter findings against more than 60 CAPAs under 21 CFR 820.100, subpart J

Confidential, Memphis, TN

Senior Supplier Quality Engineer

Responsibilities:

• For suppliers of medical device components and services, used MS Excel and MS Access VBA code to improve existing evaluation of teh inherent "risk" in using each supplier by comparing them against specifiedproducer'sand consumer'srisk and other suppliers in their class/category.
• Performed audits of selected suppliers to support Confidential & Confidential 2013 Supplier Risk Management Plan.
• Reviewed Supplier Corrective Action s (CAPA) documents, noting issues and concerns for future remediation.

Confidential, West Chester, PA

Supplier Quality Engineer

Responsibilities:

• Monitored activities for assigned supplier CAPA’s supporting supplier wif root cause analysis, definition and documentation of corrective actions, verification of actions, and monitoring of CAPA effectiveness.
• Teamed wif Purchasing to expedite incoming material flow by daily disposition of nonconforming materials at Receiving Inspection and development and release of inspection documents.
• Reviewed and approved documents and drawings for manufacturing and product inspection.

Confidential, Ann Arbor, MI

CAPA Engineer II

Responsibilities:

• Developed PowerPoint training materials for root cause problem-solving tools such as IS/IS-NOT, “5 Whys”, Pareto charts, fishbone charts, Paynter charts, and design / process FMEA methodologies.
• Developed MS Access database to analyze / cross-correlate related customer complaints and shop floor NCR’s.
• Developed failure-mode Pareto analyses to support further investigation by client’s own CAPA Engineers.

Confidential, Pennsylvania

Quality System Consulting Services

Responsibilities:

• Developed Quality System plan (including Document Control, Corrective and Preventive Action, Continuous Improvement, and Internal audit) for an industrial manufacturer.
• Reviewed Quality System for compliance wif ISO 9001:2008 and other relevant industry Standards.

Confidential, Cleveland, OH

Supplier Quality Engineer

Responsibilities:

• Teamed wif suppliers in assigned commodity groups in teh Purchasing Controls area for CT and MRI scanners to develop product and component histories and other purchasing controls records / documentation to satisfy teh requirements of ISO 13485, 21CFR-820 for medical device products, and to resolve certain outstanding FDA audit findings.

Confidential, Portage, MI

Quality Engineer

Responsibilities:

• Performed complaint investigations on high-tech hospital bed products. Documented investigations for further analysis by Post-Market Surveillance team by reviewing product histories, manufacturing records, and design data. Forwarded customer complaints that exceeded certain levels of risk to teh Regulatory Affairs group, in accordance wif Stryker procedures for medical devices and teh requirements of 21CFR-820 / ISO 13485.
• Where appropriate, contacted teh client’s field service representatives and/or teh direct product customers to obtain product safety and customer complaint data.
• Followed up on complaints that required referral to teh client’s Regulatory Affairs group and/or to teh FDA.

Confidential, Columbus, OH

Quality Systems Manager

Responsibilities:

• Structured, implemented, and maintained entire quality management system in support of ISO 9000:2008 and US railroad AAR M-1003 registrations, including Design Control, Document Control, CAPA, Continuous Improvement, supplier management including teh PPAP Process, and team-based Internal audit.
• Developed internal audit process, trained over 30 volunteer employees as internal auditors, resulting in significant decrease in customer audit findings increased sales, and improved ISO audit readiness.
• Authored numerous quality policies, manuals, procedures, and work instructions, and trained employees and management on these documents and on problem solving methods.

Confidential

Quality Engineer

Responsibilities:

• Coordinated outsourcing of over 1000 in-house- switch products to new suppliers in Taiwan and China.
• Prepared PPAP packages for submittals to automotive OEM customers.