SUMMARY

• me is a QA Professional wif hands - on experience in Quality Assurance & Project Management.
• me is highly experienced and results-oriented in managing, directing, developing & implementing entire QA Systems. Additionally, me is very experienced in developing, managing, mentoring, and leading direct reports, as well as, having successfully supported others in multiple team environments.
• me work comfortably and effectively wif suppliers/vendors and customers in North America, Europe & Asia solving problems, improving these relationships, & their respective systems.
• me is an experienced facilitator in problem solving efforts, and ensuring assignment and completion of CAPA efforts wif quality engineering, senior management, associated program departments, other employees, vendors & customers.

CORE COMPETENCIES

• Total Quality Management - TQM program implementation, oversight, and management
• ISO/AS codes and standards - ISO 9001, ISO 13485, ISO 14969, ISO 14971, AS 9100, EU Medical Device Directive (93/42 EEC) and EN 46001
• Scheduling/Conducting Internal Audits, External Audits & working wif teh external ISO/AS certification auditor(s)
• Management Representative for Quality Management System (QMS), teh Quality Manual and Procedures.
• 21 CFR 820 - Title 21 Code of Federal Regulations Part 820
• cGMP - current Good Manufacturing Practices
• Supplier Quality - US, North America, Europe & Asia
• CAPA - Corrective and Preventative Actions
• QS Remediation - Quality Systems Remediation
• MSA - Measurement System Analysis (gauging)
• pFMEA - process Failure Mode Effects Analysis
• PPAP – Production Parts Approval Process
• UDI – Unique Device Identification
• Quality Process Monitoring
• Process Flow Maps
• Control Points & Control Plans
• TMV – Test Method Validation processes
• V&V – Verification & Validation process
• QA Inspection and Testing of materials and products

PROFESSIONAL EXPERIENCE

Confidential

Quality Assurance Manager/Director

Responsibilities:

• Medical Device, Automotive, Aerospace, DoD, & commercial manufacturing Quality Assurance Manager/Director
• An expert in managing, developing, improving & implementing entire Quality Assurance Systems and personnel.
• Experienced in managing, developing, improving & implementing all elements of a company’s compliance wif ISO 9001, ISO 13485, ISO 14969, ISO 14971, AS9100, Mil-Stds, Quality System Regulations (QSR), Good Manufacturing Practices (cGMP), FDA, Customer expectations, Corporate/company requirements & other guidelines.
• Perform internal audits of all departments & organizations.
• Perform external audits of vendor quality systems.
• Manage/direct teh following Quality functions and my employees efforts to assure compliance wif teh company's Quality Management System (QMS): Customer Affairs, Quality Engineering, Contract Review, Software/Hardware/Process & Equipment Validation, Design Control, Documentation Services, CAPA, MRB, Procurement, Supplier Quality, Metrology, Product Release, Continuous Improvement, Receiving Inspection, In-process Inspection, Final Inspection & Test, Shipping, and other aspects of Quality Control.
• Provide direction to ensure compliance wif all customer requirements & government regulations involving product quality.
• Manage employees in their activities to maintain & assure continuous improvement of teh Quality Systems to achieve corporate, company & customer goals.
• Hire, train & develop Quality Engineers & Inspection Personnel to ensure quality goals are achieved.
• Provide support & leadership in Quality Engineering for existing & new product development (NPI).
• Identifies needs, and develops teh Quality Engineering function. .
• Develop, implement, & monitor performance against short & long-range plans to achieve Quality engineering objectives.
• Ensure deployment of suitable quality planning (APQP – Advanced Product Quality Planning).
• Manage CAPA (Corrective Action & Preventive Action) program dat will drive down rework & warranty costs while improving Customer Satisfaction.
• Direct and/or participate on teh Material Review (MRB) and Corrective Action (CAB) Boards.
• Support and maintain appropriate metrics to measure teh company’s performance against company quality objectives, including customer satisfaction measurements and Cost of Quality (CoQ).
• Directly interface wif both customer quality and respective engineering representatives.
• Direct and support Supplier Quality Engineers in teh development of a robust supply chain.
• Develop systems to monitor supplier performance / improvement against contract / quality requirements.
• Provide direction and assistance to procurement, supply chain / suppliers to obtain equitable resolutions to both technical and quality issues.
• Develop and implement processes and procedures for product testing and reliability for incoming receipts and life cycle monitoring.
• Develop or modify quality procedures, metrics and processes to achieve quality and on time delivery goals.
• Assist as required in all technical quality functions.
• Assist in proposals efforts.
• Assure effective communication and reporting to customers.
• Experienced Project Manager.
• Certified Leadership Trainer.
• Certified Customer Service Trainer.
• Knowledgeable in MS Project and MS Office.

Confidential

Plant Quality Assurance Manager

Responsibilities:

• As teh plant’s Quality Assurance Manager, Operated and Managed teh quality department and was responsible for all quality concerns for teh manufacturing departments and teh machine shop
• Manage QA personnel, adjusting workloads as needed, in receiving inspection, in-process inspection, final inspection and shipping, teh calibration department, supplier quality, customer source inspection, and failure analysis.
• ISO 9001 & AS9100 compliance to include scheduling quarterly Management Review meetings, acting as teh Management Representative for our Quality Management System (QMS), scheduling/conducting internal audits, & working wif teh external ISO/AS auditor for our annual audits, teh Quality Manual and Procedures.
• Owner/Manager of teh CAPA Review Board (CRB)
• Customer issues, supplier quality issues, customer quality surveys, customer assessments, MRB, CAPA, AS 9102 FAIRs, and SCARs.
• QA requirements review for contracts, sales acknowledgement, purchase orders, and Certificates of Conformance.
• Engineering Change Order (ECO) reviews & approvals for testing and QA requirements.
• Oversee Engineering requested special testing and assignment of QA personnel or outside lab services as necessary to assure teh conformance to product requirements.
• Age sensitive items (AGE) used in teh product are up to date.
• QA Training for AS9100/ISO9000, FOD, Counterfeit Parts (SAE AS5553), “Red Plague”, & similar projects
• Responsible for teh RMA (Returned Material Authorization) process to include issuance of RMA numbers, determine teh cause of teh failure of teh product, and issuance of RMA reports to teh customer.

Confidential

Quality Assurance Manager/Director/Consultant

Responsibilities:

• Quality Assurance Manager/Director
• An expert in developing, improving & implementing entire Quality Assurance Systems.
• Experienced in all elements of a company's Quality System to ensure its compliance wif ISO 9001, ISO 13485, ISO 14969, ISO 14971, AS9100, Mil-Stds, Quality System Regulations (QSR), Good Manufacturing Practices (cGMP), FDA, Customer expectations, Corporate/company requirements & other guidelines as applicable.
• Perform internal audits of other departments.
• Perform external audits of vendor quality systems.
• Ensures teh following functions and their compliance wif teh company's Quality Management System (QMS): Customer Affairs, Quality Engineering, Contract Review, Software/Hardware/Process & Equipment Validation, Design Control, Documentation Services, CAPA, MRB, Procurement, Supplier Quality, Metrology, NPI, Product Release, Continuous Improvement, Receiving Inspection, In-process Inspection, Final Inspection & Test, Shipping, and other aspects of Quality Control.
• Provide direction to ensure compliance wif all applicable customer requirements & government regulations involving product quality.
• Manage staff in activities to maintain & assure continuous improvement of teh Quality Systems to achieve corporate, company & customer goals.
• Hire, train, and develop Quality Engineers & Inspection Personnel to ensure quality goals are achieved.
• Provide support & leadership in Quality Engineering for existing and new product development (NPI).
• Identifies needs, and develops teh Quality Engineering function. .
• Develop, implement, & monitor performance against short and long-range plans to achieve Quality engineering objectives.
• Ensure deployment of suitable quality planning.
• Manage CAPA (Corrective Action & Preventive Action) program dat will drive down rework & warranty costs while improving Customer Satisfaction.
• Directly interface wif both customer quality and respective engineering representatives.
• Direct and support Supplier Quality Engineers in teh development of a robust supply chain.
• Develop systems to monitor supplier performance / improvement against contract / quality requirements.
• Provide direction and assistance to procurement, supply chain / suppliers to obtain equitable resolutions to both technical and quality issues.
• Develop and implement processes and procedures for product testing and reliability for incoming receipts and life cycle monitoring.
• Support and maintain appropriate metrics to measure teh company’s performance against company quality objectives, including customer satisfaction measurements and Cost of Quality (CoQ).
• Direct and/or participate on teh Material Review and Corrective Action Boards.
• Develop or modify quality procedures, metrics and processes to achieve quality and on time delivery goals.
• Assist as required in all technical quality functions.
• Assist in proposals efforts.
• Assure effective communication and reporting to customers.
• Experienced Project Manager.
• Certified Leadership Trainer.
• Certified Customer Service Trainer.
• Knowledgeable in MS Project and MS Office.

Confidential

Director of Quality Assurance and Regulatory Affairs

Responsibilities:

• dis Position TEMPhas oversight responsibility for all Regulatory Affairs (RA),
• Quality Assurance (QA) & Quality Control (QC) functions wif teh responsibility of managing personnel of teh Quality Departments.
• Serves as teh Quality Management System (QMS) Representative for teh company.
• Experienced in FDA Good Manufacturing Practices (GMP), ISO 9000, ISO 13485, 93/42/EEO MDD, & EN 46001.
• Ensure all elements of teh company's Quality System are in compliance wif Quality System Regulations (QSR), cGMP, FDA 510(k)'s, corporate & other guidelines.
• Oversees teh following functions and ensure their compliance wif teh company's Quality System:
• Customer Affairs,
• Quality Engineering,
• Software/Process and Equipment Validation,
• Design Control,
• Documentation Services,
• MRB (Material Review Board),
• CAB (Corrective Action Board),
• Compliance,
• Microbiology,
• Stability,
• Supplier Quality Assurance,
• Metrology,
• Product Release,
• Receiving Inspection, In-process Inspection, Final Inspection & Shipping,
• Direct staff in activities to maintain and improve teh Quality system to achieve corporate goals.
• Schedule and facilitate quarterly QMS Reviews to monitor teh effectiveness of teh company's Quality System.
• Provide monthly trending on key elements of teh Quality System to monitor process and product performance.
• Schedule and conduct internal and supplier Quality System compliance assessments.
• CAPA (Corrective Action & Preventive Action) Review Board.
• Manage inspections performed by outside regulatory bodies and customers.
• Ensure timely resolution of observations.
• Support Regulatory Affairs in preparing regulatory submissions.
• Prepare and manage teh QA/QC departmental budgets.
• Ensure competent staffing & organization of resources achieving corporate goals and compliant execution of all QA/QC functions.
• Update Quality Manual (QM) & quality procedures.

Confidential

Senior Sector Manager

Responsibilities:

• Established domestic and international software (SW) development strategies and methodologies for all of Motorola’s Semiconductor Sector (Division).
• Directed teh management of software quality assurance for teh sector.
• Established SW project management processes, testing processes, configuration management (CM) processes, SW quality assurance (QA) processes, and SW engineering development processes for products and for testing environments dat support Six Sigma (6-Sigma), S.E.me. C.M.M. and me.E.E.E. standards for SW development.
• Provided coaching and mentoring services for sector and worldwide Motorola facilities on new and existing projects.
• Established and managed SW QA organizations on sector projects to include broadband, transportation, home entertainment, and personal communications.
• Managed teh CAPA Review Board (CRB)
• Interfaced wif executive management, as well as management teams for Design and SW Engineering.
• Responsible for metrics programs identifying project goals and measurements toward achieving those goals.

Confidential

Senior Quality Assurance Manager

Responsibilities:

• Provided domestic and international management, mentoring, coaching, teaching, and training services in Object Oriented Technology (OOT) for multiple commercial and department of defense (DOD) clients throughout North America. Specialized in Engineering Processes, Project Management (PM), Test Methods, and Quality Assurance Strategies.
• Provided consulting for LMC client companies on new and existing projects.
• Established and provided project management, testing, CM, QA, and engineering processes for client-server and mainframe environments dat support C.M.M. and me.E.E.E. standards.
• Developed supplier quality metrics programs and measurements.
• Provided training in Object Oriented Analysis and Design (OOAD); and, Integral Quality through Inspection and Test
• Interfaced wif executive management and program managers of Design, SW Engineering, Information Management (IT), Marketing, Customer Training, and Technical Support for LMC and multiple client companies to provide solutions.
• Responsible for establishing divisional requirements for test methodologies, test processes, test concepts and test strategies employed, and test standards for multiple SW development contracts in teh object oriented (OO) environment for teh U.S. Mid-West Region.
• Responsible for all aspects of test functions for design, requirements capture, unit case model development, class test strategy, system integration test, system test, and release of SW products.
• Composed teh Master Test Validation and Verification (V&V) Plan. Managed and directed teh efforts of multiple test leads and their testing teams.
• Successfully tracked, shortened, and completed through means of proper methodology and testing tools, teh prescribed product release timelines. Teh goals of teh released features were always achieved.
• Interfaced wif executive management and program managers of Design, SW Engineering, Marketing, Customer Training, and Technical Support.

Confidential

Chairman of teh Quality Implementation Team

Responsibilities:

• Developed, and directed corporate reliability standards for Confidential Medical Systems. Successfully leveraged reliability throughout teh design, development, and roll out phases of product development by establishing overall corporate guidelines.
• Responsible for all system test functions for design, development, and manufacturing of a Nuclear Imaging Camera.
• Created teh Master Validation and Verification Plan for teh Design & Development Planning, Design Review, Design Verification, Design Validation, Design Transfer, Design Changes, Defect Tracking, System Release Process and Design History File Maintenance. Accomplished teh above effort wif a small team of 7 full time engineers and 16 staff from multiple departments.
• Interfaced wif executive management, as well as teh associated managers of Hardware and SW Engineering, Marketing, Regulatory Affairs (FDA), Manufacturing, Customer Training, Technical Support, and Service.
• Provided proper methodology and testing tools, which supported teh prescribed product release and teh project goals of teh released features.
• Implemented an on-line automated System Requirement Specifications Tracking System. Linked teh design documents, teh test plans, teh test procedures, and defect reports to maintain teh traceability, which was assessable from any platform wif any web browser.
• Enacted improvements of teh quality systems wifin teh corporation.
• Coordinated teh cross-divisional establishment, use, and training of SOPs (Standard Operating Procedures), Hazard/Risk Analysis, and SW Verification and Validation (V&V) Training.