Quality Assurance

Medical Device, Aerospace, Automotive, Electronic Industries

I am a management Professional with hands-on experience in Aerospace, Medical Devices and Automotive industries in Quality Assurance & Project Management.

I am highly experienced and results-oriented in managing, directing, developing & implementing entire Quality Systems utilizing PMP, Lean, Six Sigma and Agile methodologies. Additionally, I am very experienced in team-building, developing, managing, mentoring, and leading direct reports, as well as, having successfully supported cross functional teams in multiple group environments.

I work comfortably and effectively with suppliers/vendors and customers in North America, Europe & Asia solving problems, improving these relationships, & their respective systems.

I am an experienced facilitator in problem solving efforts, and ensuring assignment and completion of Quality Assurance efforts with quality engineering, senior management, associated program departments, other employees, vendors & customers.

EDUCATION:

UNIVERSITY OF ARKANSAS AT FAYETTEVILLE – BACHELOR’S DEGREE (MAJOR: PHYSICS; MINOR: ELECTRONICS)

KNOWLEDGE & SKILLS SUMMARY:

15 plus years working in manufacturing plants & corporate as QA manager/director

Total Quality Management – TQM program implementation, oversight, and management

QMS / BMS – Quality Management Systems / Business Management Systems

ISO / AS codes and standards – AS 9100, ISO 9000, ISO 13485, ISO 14969, ISO 14971, AS 9102, EU Medical Device Directive (93/42 EEC) and EN 46001

Management Representative for Quality Management System (QMS), the Quality Manual and Procedures.

FDA 21 CFR (Code of Federal Regulations) Part 820 – the QSR (Quality System Regulation) outlining cGMP (Current Good Manufacturing Practice) regulations that govern Medical Devices

Scheduling/Conducting Internal Audits, External Audits & working with the external ISO/AS certification auditor(s)

HHE/D (Health Hazard Evaluation/Determination) mediation and resolution

Supplier Quality – US, North America, Europe & Asia

MRB – Material Review Board

NCR – Non-Conformance Reporting

CAPA – Corrective and Preventative Actions

Quality Alerts

QS Remediation – Quality Systems Remediation

FDA Remediation of FDA Form 483 Observation’s and Warning Letters

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

Training of employees and engineers on Quality Compliance and Systems

Knowledgeable in MS Project, Visio and MS Office Suite (MS Word, MS Excel, MS PowerPoint, MS Outlook, etc.)

CAREER HISTORY DETAILS:

B&H Quality Assurance Management Solutions - LLC

Medical Device, Automotive, Aerospace, DOD, Commercial & Scientific Manufacturing/Industries

(Owner) Quality Assurance Manager/Director – (2016 to Present) Austin, TX

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 with 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 the following Quality functions and my employees efforts to assure compliance with the 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 with all customer requirements & government regulations involving product quality.

Manage employees in their activities to maintain & assure continuous improvement of the Quality Systems to achieve corporate, company & customer goals.

Hire, train & develop Quality Engineers & Inspection Personnel to achieve quality goals.

Provide support & leadership in Quality Engineering for existing & new product development (NPI).

Identifies needs, and develops the 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 that will drive down rework & warranty costs while improving Customer Satisfaction.

Manage HHE/D investigations and resolutions

Direct and/or participate on the Material Review (MRB) and Corrective Action (CAB) Boards.

Support and maintain appropriate metrics to measure the company’s performance against company quality objectives, including customer satisfaction measurements and Cost of Quality (CoQ).

Directly interface with both customer quality and respective engineering representatives.

Direct and support Supplier Quality Engineers in the 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, MS Visio and MS Office.(Word, Excel, PowerPoint, Outlook, etc.)

Triple Crown Consulting –Austin, TX

Contracting Agency

Quality Assurance Contractor – (2018 to 2019) Phoenix, AZ

Quality Assurance Manager for one of Triple Crown Consulting’s customers in Phoenix AZ.

Act as interim Sr. Quality Assurance Manager for MRCY’s Space Group.

Maintains technical company and regulatory quality assurance and control systems in the manufacturing facility.

Assures and specifies the execution of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products.

Ensures activities and items comply with both company quality assurance specifications and applicable government standards, such as GMPs and ISO regulations. Identifies trends in the inspection of finished products, in-process materials and bulk raw materials, and recommends corrective actions when necessary.

Organizes, documents, and interprets inspection support documents and records.

Reviews and defines Quality procedures and standards in conjunction with the rest of the BU (business unit) management team that meet the needs of their customers and their market.

Works on complex assignments requiring independent action and a high degree of initiative to resolve issues

Ensures that business unit policies and procedures align with corporate vision.

Works with purchasing staff to institute quality requirements from external suppliers and monitors their performance.

Acts as liaison with customers' auditors ensuring the execution of corrective action and compliance with customers' specifications

Audits manufacturing procedures and processes, both internal and at suppliers

Timely reviews and dispositions of customer quality flow downs on purchase orders

Assesses product specifications and procedures of the company and its suppliers, and compares with customer requirements.

Coordinates source inspection activities by the customer and government.

American Contract Group –North Andover, MA

Contracting Agency

Quality Assurance Contractor - (Oct 2017 – Aug 2018) Davenport, IA

Quality Engineer for one of American Contract Group’s customers in Davenport, IA.

Aerospace Quality Engineer for Cobham plc, Mission Systems.

Contract Review with an Aerospace background.

Review all the contracts from Cobham’s various aerospace customers to assure customer and company compliance with Cobham’s quality group.

Work with the contract group to verify and validate compliance with the terms of the customer’s contract.

Escalate contract concerns to Cobham’s executive leadership team.

Co-ordinate with other Cobham departments to assure the contract requirements are achievable and correct.

Work with internal quality organizations to pass down contract requirements.

Connectronics Corp

High Voltage Cable Industry supplying product for the Automotive, Commercial, Military, Medical, & Scientific Sectors

Quality Assurance Manager – (2013 to 2016) Toledo, OH

As the plant’s Quality Assurance Manager, Operated and Managed the quality department and was responsible for all quality concerns for the manufacturing departments and the machine shop

Manage QA personnel, adjusting workloads as needed, in receiving inspection, in-process inspection, final inspection and shipping, the calibration department, supplier quality, customer source inspection, and failure analysis.

ISO 9001 & AS9100 compliance to include scheduling quarterly Management Review meetings, acting as the Management Representative for our Quality Management System (QMS), scheduling/conducting internal audits, & working with the external ISO/AS auditor for our annual audits, the Quality Manual and Procedures.

Owner/Manager of the 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 the conformance to product requirements.

Age sensitive items (AGE) used in the product are up to date.

QA Training for AS9100/ISO9000, FOD, Counterfeit Parts (SAE AS5553), “Red Plague”, & similar projects

Responsible for the RMA (Returned Material Authorization) process to include issuance of RMA numbers, determine the cause of the failure of the product, and issuance of RMA reports to the customer.

B&H Quality Assurance Management Solutions - LLC

Aerospace, DOD, Automotive, Medical Device, Commercial & Scientific Industries

(Owner) Quality Assurance Manager/Director/Consultant – (2002 to 2013) Austin, TX

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 with 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 the following functions and their compliance with the 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 with all applicable customer requirements & government regulations involving product quality.

Manage staff in activities to maintain & assure continuous improvement of the Quality Systems to achieve corporate, company & customer goals.

Hire, train, and develop Quality Engineers & Inspection Personnel to achieve quality goals.

Provide support & leadership in Quality Engineering for existing and new product development (NPI).

Identifies needs, and develops the Quality Engineering function. .

Develop, implement, & monitor performance against short and long-range plans to achieve Quality Engineering objectives.

Ensure deployment of suitable quality planning.

B&H Quality Assurance Management Solutions – LLC

(Continued from previous page)

Manage CAPA (Corrective Action & Preventive Action) program that will drive down rework & warranty costs while improving Customer Satisfaction.

Directly interface with both customer quality and respective engineering representatives.

Direct and support Supplier Quality Engineers in the 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 the company’s performance against company quality objectives, including customer satisfaction measurements and Cost of Quality (CoQ).

Direct and/or participate on the 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.

TERARECON, INC.

Medical Device Industry

Director of Quality Assurance and Regulatory Affairs (February 2002 to October 2002) California

This Position has oversight responsibility for all Regulatory Affairs (RA),

Quality Assurance (QA) & Quality Control (QC) functions with the responsibility of managing personnel of the Quality Departments.

Serves as the Quality Management System (QMS) Representative for the company.

Experienced in FDA Good Manufacturing Practices (GMP), ISO 9000, ISO 13485, 93/42/EEO MDD, & EN 46001.

Ensure all elements of the company's Quality System complies with Quality System Regulations (QSR), cGMP, FDA 510(k)'s, corporate & other guidelines.

Oversees the following functions and ensure their compliance with the company's Quality System:

oCustomer Affairs,

oQuality Engineering,

oSoftware/Process and Equipment Validation,

oDesign Control,

oDocumentation Services,

oMRB (Material Review Board),

oCAB (Corrective Action Board),

oCompliance,

oMicrobiology,

oStability,

oSupplier Quality Assurance,

oMetrology,

oProduct Release,

oReceiving Inspection, In-process Inspection, Final Inspection & Shipping,

Direct staff in activities to maintain and improve the Quality system to achieve corporate goals.

Schedule and facilitate quarterly QMS Reviews to monitor the effectiveness of the company's Quality System.

TERARECON, INC.

(Continued from previous page)

Provide monthly trending on key elements of the Quality System to monitor process and product performance.

Schedule, 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 the 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.

MOTOROLA INCORPORATED

Semiconductor Products Sector

Senior Sector Manager of Software Quality Engineering (September 1999 to February 2002) Texas

Established domestic and international software (SW) development strategies and methodologies for all of Motorola’s Semiconductor Sector (Division).

Directed the management of software quality assurance for the 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 that support Six Sigma (6-Sigma), S.E.I. C.M.M. and I.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 the CAPA Review Board (CRB)

Interfaced with 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.

LOCKHEED MARTIN CORPORATION

Aerospace and DOD Industries

Senior Quality Assurance Manager (1996 – 1999) Illinois

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 that support C.M.M. and I.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 with 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 the object oriented (OO) environment for the 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 the Master Test Validation and Verification (V&V) Plan. Managed and directed the efforts of multiple test leads and their testing teams.

Successfully tracked, shortened, and completed through means of proper methodology and testing tools, the prescribed product release timelines. The goals of the released features were always achieved.

Interfaced with executive management and program managers of Design, SW Engineering, Marketing, Customer Training, and Technical Support.

SIEMENS MEDICAL SYSTEMS

Medical Devices

Sector Chairman of the Quality Implementation Team (QIT) (1995 – 1996) Illinois

Developed, and directed corporate reliability standards for Siemens Medical Systems. Successfully leveraged reliability throughout the 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 the Master Validation and Verification Plan for the Design & Development Planning, Design Review, Design Verification, Design Validation, Design Transfer, Design Changes, Defect Tracking, System Release Process and Design History File Maintenance. Accomplished the above effort with a small team of 7 full time engineers and 16 staff from multiple departments.

Interfaced with executive management, as well as the 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 the prescribed product release and the project goals of the released features.

Implemented an on-line automated System Requirement Specifications Tracking System. Linked the design documents, the test plans, the test procedures, and defect reports to maintain the traceability, which was assessable from any platform with any web browser.

Enacted improvements of the quality systems within the corporation.

Coordinated the cross-divisional establishment, use, and training of SOPs (Standard Operating Procedures), Hazard/Risk Analysis, and SW Verification and Validation (V&V) Training.

LOCKHEED MARTIN – MISSILES AND SPACE SYSTEMS

Quality Assurance Engineering (1983 – 1995) Texas

- Quality Testing Engineer

Designed, developed, and executed tests plans and procedures.

-Program Office Quality Assurance Engineer

Performed various Quality Engineering (QE) functions for compliance of ISO 9000, DoD Quality Systems, and Mil-Spec for systems, Hardware (HW), and Software (SW).

-Quality Assurance Engineering Field Representative

Performed extended contracted field assignments to establish, maintain, and support Quality Assurance (QA) requirements.

ROCKWELL INTERNATION – SHUTTLE ORBITER DIVISION, Johnson Space Center (JSC)

Project Engineer (1981 – 1983) Texas

NASA project Engineer on the Space Shuttle program at Johnson Space Center, Houston, Texas

Guidance, Navigation, and Flight Dynamics Engineer

Compiled and assessed the NASA Space Shuttle’s navigation system, the Inertial Measurement Unit (IMU) operations, rendezvous radar and proximity operations. Responsible for any anomaly detection and resolution thereof.

Provided system test support to the Shuttle Avionics Integration Laboratory (SAIL) at JSC.

Provided engineering support for the testing of the payloads of the Space Shuttle.

Interfacing between NASA personnel and plant engineering to coordinate the tasks among Houston, Texas and Downey, California facilities with emphasis on the shuttle payload systems.

Maintained configuration control of NASA’s space shuttle vehicle - OV 95. Reviewed, approved, and coordinated hardware deliveries and modifications.

WHIRLPOOL CORPORATION – FORT SMITH DIVISION

Quality Control Supervisor (1976 – 1981) Arkansas

Directly supervised Quality Control (QC) technicians in Whirlpool’s manufacturing Quality Laboratory.

Directly supervised Quality Control (QC) Inspectors in the Receiving Inspection Department, the In-Process Manufacturing Quality Control (QC) Inspectors on the manufacturing lines, and Quality Control (QC) Inspectors in the final quality inspection and shipping departments.

Worked with suppliers in the resolution of quality issues.

Worked with Whirlpool design and production engineers in the resolution of product quality issues.

*Prepared daily and weekly Quality Control status reports for upper management.

Participated in the resolution of customer quality issues on returned units.

Performed analysis on quality control issues that occurred in the manufacturing plant

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