Quality Engineer Design Assurance

Experienced Sr. Design Assurance Quality Engineer Seeking Position as Design Quality Engineer A highly skilled and experienced Design Assurance Quality Engineer with a strong background in design control deliverables, quality plans execution, and continuous improvement. Looking to leverage my skills and experience in a Design Quality Engineer role.

Work Experience

Sr. Quality Engineer – Contractor

Catalyst Life Sciences - Duluth, GA

MicroTransponder (Remote)

March 2024 – September 2024

Responsibilities include: Performing Gaps analysis on the DHF files utilizing ISO14971:2019. Determine if the DHF requires remediation, create a GAP analysis, and audit the Design procedures to make recommendations for remediation. Create a QMS Standards Gap analysis plan and a remediation execution plan.

Sr. Design Assurance Quality Engineer Active Device

BBraun - Allentown PA (Remote)

May 2022 – May 2023

Responsibilities include support all Company initiatives identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Performs other related duties and responsibilities, on occasion, as assigned. Participates in and supports the implementation, development, enhancements, and modifications to software source code, scripts, and procedures; Debugs, troubleshoots, and isolates software problems as well as offers strategic solutions, analysis, and advice regarding identified issues for future development; Identifies parameters, structure, and critical test components. Complete Compliance reviews of IEC 14971, IEC 60601-1, IEC 60601-1-11BS EN 60601-1-6, IEC 62304, ISO 14708-1 and 14708-3, BS EN 45502, BS EN 14971, and ISO 10993-1, 3, 5, 6, 7, 11, and 12.

Sr. Design Assurance Quality Engineer

Oxford - Rocklin, California

DePuy-Mitek Division, Johnson & Johnson– Raynham Mass (Remote)

September 2020 – May 2022

Responsibilities include assess risk documents for Gaps and complete Gap assessment report for completeness. Convert and align risk management files with EU MDR updates per, FDA 21 CFR Part 820, ISO 13485 Review design test and inspection method protocols, and test method validation protocols. Ensure DHF content completion, integrity, and regulatory & standards compliance; for (LVR) labeling verification report.

Sr. Design Assurance Quality Engineer - Contractor

Aerotek

Abbott • Plano, TX

October 2015 – February 2020

Responsibilities include led on-time completion of Design Control Deliverables, Created and ensured on-time execution of Quality Plans for internal development, Clinical Product Development (CPDP), and design change projects. Convert and align risk management files with the EU MDR updates per, FDA 21 CFR Part 820, ISO 13485 Support design test and inspection method development, and lead test method validation activities, Ensure DHF content completion, integrity, and regulatory & standards compliance; for (LVR) labeling verification report. Support (NPS) non-product software qualification, including but not limited to writing test protocols for V&V and ensuring validation of all (NPS) qualification, supporting Research and Development Test Method Validation by reviewing/approval, and authoring (TMV’s) for System protocol for compliance testing.

Sr. Quality Engineer - Contractor

Real Staffing, Group

(Phillips Medisize - Plastics) Eau Clare Wisconsin

February 2015 - September 2015

Responsibilities include root cause analysis, problem solving, continuous improvement, and related corrective and preventive action as they relate to complaints, non-conforming material, post-market surveillance (PMS), and other quality data, Develop and manufacture/procure test equipment and inspection systems (tooling, fixtures, gauging, instruments, equipment, software, etc.), including appropriate calibration and preventive maintenance, disposition of non-conforming material and lead for (MRB) Material Review Board. Quality reporting: tracking; compiling; and reporting quality metrics. Review specifications to ensure appropriate designation, specification, dimensioning, and tolerance related to inspection.

Sr. Design Assurance Quality Engineer - Contractor

Aerotek • Richardson, TX

July 2011 - December 2014

(SJM) Neuromodulation Division – Plano Texas

Responsibilities include working with peers in Research and Development, Process Development, and Clinical Affairs with expert level knowledge in Design Processes and Controls, Risk Management, Experimentation and its associated documentation, and Protocol and Report Creation to ensure products come out of the Development processes well captured in documentation and with demonstrated robust capability and minimal risk, representing Design Control activities to external reviewers. Perform risk management and planning activities (Hazard Analysis, Design/Application FMECA, Software FMECA, and Fault Tree Analysis) to ensure products and processes are safe and effective. Review customer complaints, propose corrections or corrective actions, to the product -hardware/software design or usability issues within the defect management system, also supported Research and Development Test Method Validation activities reviewing, approving and authoring (TMV’s) for System protocol for compliance testing. Complete Compliance reviews of IEC 14971, IEC 60601-1, IEC 60601-1-11BS EN 60601-1-6, IEC 62304, ISO 14708-1 and 14708-3, BS EN 45502, BS EN 14971, and ISO 10993-1, 3, 5, 6, 7, 11, and 12.

Sr. Quality Engineer – Electrical

Orthofix Inc – Lewisville, Texas

April 2003 – March 2011

Responsibilities include develop testing and inspection strategies to proactively minimize design and process problems and correct problems that occur for new and existing electrical/electronic devices. The position ensures compliance with quality systems and other standards and regulations, company quality requirements, and corporate objectives. Input and approval for design verification and validation testing of new designs and design changes (including product software/firmware verification) to ensure product design quality and integrity, Input and approval for internal and supplier manufacturing equipment/processes/systems (IQ/OQ/PQ) to ensure process capability and product/process quality; direct responsibility of the same for quality department equipment/processes/systems, including quality department items developed for use by suppliers, Validation of software/firmware used in products and testing systems used to determine product or process conformance, Input and approval for validation of automated processes and software used in the quality system. Determine appropriate tests, inspections, and validations to ensure components and products meet specification requirements, Supplier qualification, and approval, including related controls stated above, Root cause analysis, problem-solving, continuous improvement, and related corrective and preventive action as they relate to complaints, non-conforming material, post-market surveillance (PMS), and other quality data, Develop and manufacture/procure test equipment and inspection systems (tooling, fixtures, gauging, instruments, equipment, software, etc.), including appropriate calibration and preventive maintenance, disposition of non-conforming material. Input to, and development of, specifications, standards, test protocols, test reports, procedures, and other documentation and records related to the above-listed responsibilities, Quality system compliance in above-listed areas, Quality reporting: tracking; compiling; and reporting quality metrics, Review specifications to ensure appropriate designation, specification, dimensioning, and tolerance as they relate to inspection.

World Wide Logistics Coordinator Manager

Currency Systems International, INC. - Irving, Texas

April 2000 – April 2003

Responsibilities include managing, all areas of distribution including; shipping, receiving, inventory control, and replenishment. Prioritize inventory level for Depot shipment by performing, the following duties: Review production schedules and related information for Depot orders, to meet site and Depot Inventory level requirements, coordinating and disposition of returned and used or damaged product from the field for repair or refurbishment. Responsible for coordinating quarterly inventory count with the field service Engineer and Depot Managers and reconciliation of lost or missing product to be reported to the Accounting Department Director. Set up initial spare parts to be shipped with systems. Designed and supported the integration of a parts tracking system, developed Spare Parts inventory (CD). Key Member of the ECN team and processor of ECN for logistics worldwide. Perform Quality inspections of refurbish equipment and write ECN to have them repaired. Write test procedures to test and reship refurbished and returning equipment back into service.

Product Manager /Manufacture Engineer

XCI Corporation - Dallas, Texas

January 1998 – April 2000

Responsibilities include all aspects of manufacturing and support of equipment produced for integration with energy management systems (HVAC). Primary responsibilities: Set MRP parameters to ensure appropriate inventory levels, quarterly inventory cycle count, including an end of year count and inventory report to accounting, shipping, inventory control. Oversee parts ordering for turnkey manufacturer, delivery, and fabrication of production HVAC control devices, Qualification of all suppliers. Reliability testing of integrated circuits, and Hardware and software qualification testing. Trade Show coordinator, set up, tear down, and technical advisor during the show. Customer support including application engineering and warranty resolution. Also responsible for developing all internal standards and documentation related to these activities.

Education

DEVRY INSTITUTE OF TECHNOLOGY

Electronics Technician Diploma

1983 • 1985

DeVry University

Bachelors of Electronics Engineering Technology

1986 • 1989

Skills

Oscilloscope, Spectrum Analyzer, Flukes Series Scope meters, Frequency Counter, Frequency Generator, Analog & Digital Power Supply, Voltage & Current Probes, Electrical Wire Wrap & Manual Wire Wrap Tool, SMT Solder & De-soldering Stations, Environmental chambers, Microsoft Windows, Office 2007 including Word, Excel, Access and Project, Visio Flow charting

Certifications

ASQ – Member

CQE, CSSGB

AAMI – Design Control Requirements and Industry Practice

AAMI – Quality System Requirements and Industry Practice

AAMI – General Principles of Software Validation

AAMI – Integrating Risk Management into the Quality System

UL – Medical Equipment and Systems: Designing for Compliance to IEC 60601-1

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