Quality Assurance

ELIZABETH T. HALE

MAILING ADDRESS: ** Wits End Drive, Apt. 3E • Hamburg, New Jersey 07419

973-***-**** • *********@*****.***

QUALITY SYSTEM MANAGER (QSM) ● QMS COORDINATOR • SENIOR QUALITY ENGINEER

Dynamic, dedicated and versatile quality engineering professional, with a wealth of hands-on experience propelling corporate performance and profitability while managing complex tasks in fast-paced and deadline-driven environments. Critical thinker, with significant strengths in managing multiple simultaneous projects. Routinely exceed expectations through creative problem-solving, meticulous attention to detail and superb time management abilities. Exceptional interpersonal, communication and presentation skills with all levels of staff, management, vendors and clients. Talent for leading, training and mentoring cross-functional teams to meet and exceed corporate goals. Results oriented and focused decision-maker, adept at managing priorities.

Core Competencies

Manager - Quality Management Systems● Internal QA Audits ●Quality Engineering •Project Management • Document & Data Control ● Process & Performance Improvement • ISO 9001:2008/AS9100, ISO 13485:2003 Standards, 21CFR Part 803 MDR, FDA CFR 21 820, π and CE directives Compliance • CAPA ●SPC • Investigative Research & Analysis ● Regulatory Compliance • Team Leadership, Training & Mentoring ● Policy/Procedure Development • Technical Documentation • Requirements Assessment • Risk Management ● Cost Estimates & Quotes • Product Safety Assurance • Collaborative Teamwork • Manufacturing Processes ● Reports & Presentations • Product Complaint Investigations • Client/Vendor Relationship Management ● Strategic Planning • Negotiation & Issue Resolution • Aerospace Industry • FAA part 21.3 and 21.613 Regulations ● IPC 610 Standards

PROFESSIONAL EXPERIENCE

CAVAGNA NORTH AMERICA, Somerset, New Jersey – 2/2012 to 9/2012

One of the world’s leading manufacturers of equipment and fittings for propane and compressed gas storage, and medical gas controlling devices.

Quality System Manager and Internal Auditor

Oversight of the company’s Quality Management System, and:

● Updated the Quality Manual, the Customer Satisfaction procedures, process flows (utilized Visio) and work instructions with the “Incident Reporting and Product Recall” procedures required for CAVAGNA NA to be approved to the Canadian Medical Devices Regulations, ISO 13485:2003 and of FDA, CFR 21 Part 803 MDR, UL, for manufacturing and supplying Medical Devices to the trade with Canada. Incorporated EC Directives, as required.

● Compiled the company’s Management Review covering 12 months of 2011, and prepared for CAVAGNA North America surveillance audit with Apragaz, in May 2012.

● Successfully completed Apragaz ISO 9001:2008 surveillance audit.

● Performed two sessions of internal quality audits in order to verify the Quality Management System.

● Liaised with auditors, planned and requested formal CAPA actions to ensure execution of corrective actions, while maintaining company compliance objectives.

● Utilized Microsoft Office Excel for reporting, logging, tables and SPC charting of Customer Complaints, RMAs, internal and external audit findings, and product issues.

AERO PANEL CORP. & INSTRUMENT SPECIALTIES CO., Boonton, New Jersey • 4/2002 to 5/2011

Sister companies with shared management, specializing in the design and manufacture of aviation control panels and engine monitoring instrumentation.

QMS ISO9001 Coordinator, QMS Internal Auditor & Document/Data Control Coordinator

Controlled all aspects of the Quality Management System, including all associated data and documentation. Maintained and updated the Quality Manual, developed and enforced quality policies/procedures, trained staff and provided appropriate access to QMS documentation for clients, staff, management and regulatory authorities. Performed internal quality audits to ensure compliance with client requirements, ISO9001/AS9100 standards and applicable FAA regulations. Identified and implemented continuous process improvements and corrective/preventative

actions. Verified, documented and presented audit results to senior management. Communicated with clients, vendors, external auditors and other interested parties and resolved all quality-related issues as they arose. Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; product & process controls; Corrective Action and Preventive Action (CAPA), complaints & risk management, product and process quality improvement, using SPC tools such as six sigma, DOE, DFR, etc.

● Increased revenues and enhanced efficiencies by implementing and promoting innovative, enterprise-wide quality improvement programs.

● Hosted company QMS 9001 Registration Certification and Recertification audits, FAA ACSEP (“Aircraft Certification System Evaluation Program”) Audits.

● Recognized by senior management for outstanding performance in consistently achieving corporate and client quality goals, fully compliant with ISO9001/AS9100 Standards and FAA Title 14 Part 21 Regulations.

KEARFOTT GUIDANCE & NAVIGATION CORPORATION, Wayne, New Jersey • 1/1997 to 2/2001

Leading designer and manufacturer of aviation guidance and navigation systems for both military and commercial markets.

Senior Quality Engineer

Assessed client requirements and prepared Requests for Proposal/Request for Quotation documents for new program proposals. Developed quality procedures, including program quality, testing, inspection and nonstandard sampling plans. Managed the preventative/corrective action program for troubleshooting and issue resolution. Ensured compliance with all company procedures, configuration provisions, quality standards and regulatory requirements. Furnished technical direction, supervision and mentoring to the quality assurance team. Utilized DOE, FMEA, GD&T, SPC methods to control special process capabilities. Supervised contractors and temporary workers, authored inspection/work instructions and technical documentation, headed product complaint investigations and resolved issues. Provided monthly progress reports to senior management.

Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.

● as a key member of the Material Review Board and Configuration Control Board, reviewed project material and documentation, oversaw control of nonconforming material, and approved all component specifications, assembly drawings, project documents and change requests.

● Utilized Microsoft Office Excel for reporting, logs, tables and SPC charting of Customer Complaints, RMAs, internal and external audit findings, and product issues.

OMEGA CIRCUITS & ENGINEERING CORPORATION, New Brunswick, New Jersey • 1993 to 1996

Manufacturer of high-technology printed circuit boards for military and civilian applications.

Quality Assurance Supervisor

Directed all Quality Assurance system and inspection program functions, including test runs, audits, first pieces and incoming/in-process/final inspections, supervising a team of 6 inspectors. Maintained QA documentation and records. Ensured compliance with corporate policies/procedures, the QA manual, quality standards and applicable regulations. Trained and mentored personnel, administered government qualification testing, monitored processes using Statistical Process Control techniques and recommended improvements based on data analysis.

● Improved the minimum manufacturing cycle time of the printed wiring board from 8 days to 2 days.

● achieved a significant decrease in the 48% defect/scrap rate by implementing an aggressive corrective action program

Early Career (details on request):

● Program Quality Engineer, PACIFIC ELECTRO DYNAMICS (A division of the Olin Defense Group), Redmond, Washington

● Lighting Design Engineer, KORRY ELECTRONICS (A division of CRITON Technologies Defense Group), Seattle, Washington

EDUCATION / PROFESSIONAL DEVELOPMENT ●US Citizen

Bachelor of Science, Civil Engineering

Bucharest Institute of Civil Engineering, Bucharest, Romania

Statistical Process Control, Bellevue Community College, Bellevue, Washington

Certified Quality Engineer Refresher Course, American Society for Quality

●Supplier Statistical Process Control, General Dynamics ● IPC 610 Standards and High Reliability Soldering Technology, Boeing ●High Reliability Soldering Technology, Pacific Electro Dynamics ●TQM Quality Management Workshop, Olin Defense Group

COMPUTER SKILLS: Microsoft Office (Word, Excel, Access & Power Point), Visio, MAS200, Job Boss

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