Senior Quality Engineer Med Device & Manufacturing

Ronald M. Scott

**** ** **** ***. 813-***-****

Ocala, FL 34479 **************@*****.***

Summary

Quality professional with experience in Medical Device and Commercial manufacturing. Performs well in a Team environment. Experience/Skills include:

ISO 9001 & 13485 Quality Engineering/Systems/Management Six Sigma principles

Lean Manufacturing FDA/cGMP regulations Supplier Management

Design Controls ISO 14001 Management Review

Internal/External Audits MS Office – Word, Excel, PowerPoint

Professional Experience

Lockheed Martin 07/2025 – Present

Senior Supplier Quality Engineer.

Responsible for ensuring that purchased products meet overall specifications, quality/regulatory requirements, and customer expectations. Serve as key liaison between operations, suppliers, and customers, driving quality and continuous improvement.

•Interfacing with customers, suppliers, and program personnel on quality related issues.

•Analyzing and resolving issues associated with components, assemblies, and materials provided by suppliers.

•Leading containment activities and issuing corrective action requests to suppliers.

•Creating and assigning inspection plans, attending program corrective action meetings.

•Hosting quality system audits, supporting internal corrective action programs, and training inspectors and quality professionals.

Artemis Plastics, a Division of Apollo Renal Therapeutics, LLC 02/2023 – 02/2025

Independent Quality Consultant (Quality Management System Support)

Assisting CEO and Quality Manager with adding an additional Manufacturing facility to their existing ISO 13485 & 9001 Certificate.

•Updating the QMS documents required to support the additional facility.

•Review past audit findings and generate Corrective and Preventive actions to address the findings.

•Assist with other QMS areas of concern to demonstrate “Continuous Improvement”.

Philips Healthcare (Gainesville, FL & Latham, NY) 12/2016 – 12/2022

Sustaining Supplier Quality Engineer

Drive Supplier Quality activities for critical suppliers (focus on Cable Commodity), setting a high standard and fast response expectations so quality issues are prevented or minimized. Ensure that suppliers have appropriate capabilities to deliver conforming material(s).

•Manage and conduct on-site and remote supplier audits (Risk based)

•Supplier Performance Monitoring, reporting, improvement and development)

•Apply Advance Product Quality Planning (APQP) methodology for part approvals.

•Analysis of defects for determining if supplier caused and then notified.

•Initiate / submit Supplier Corrective Actions (SCAR)

•Assess and coordinate Supplier Change Requests

•Provide detailed guidance to others.

•Make additions/changes/deletions to Approved Supplier List

Winco Mfg., LLC 11/2015 – 12/2016

Quality & Regulatory Director

Provide Quality and Regulatory direction for compliance to FDA (Quality System Regulation), ISO 9001, ISO 13485 (Quality Management Systems), ISO 14971 (Risk Management) and Canadian Medical Device Regulation (CMDR). Management Representative and Official Correspondent responsible for leading Management Reviews, FDA Registrations/Reporting, CAPA Review Boards and Notified Body Audits.

•Supplier Controls (Approval, Audits & Monitoring)

•Quality Systems Documents

•Design Reviews

•Document Control

•Calibration Management

•Receiving/In Process Inspection and Product Final Acceptance

•Corrective and Preventive Actions

Invivo Diagnostic Imaging (Philips Healthcare) 9/2005 – 11/2015

Quality Systems Team Leader

Management of Quality Systems for Regulatory Compliance Readiness and directing the Quality Systems team in quality, regulatory, and business support activities for Supplier Quality, Training, Quality

System Management, Audit Management, Notified Body management (TUV), Receiving Inspection activities and Calibration Management.

•Quality Systems Documents

•Supplier Quality Initiatives (Approvals, Monitoring, PPA/FAI)

•Audits & Inspections (Internal & External)

•Training

•Management Review (Deputy Management Representative)

Quality Engineer

Oversee operation of Incoming material inspection, Calibration program, Non-Conformance Reporting, Corrective and Preventative Action, Supplier Quality (Certifications, Ratings, and Corrective actions), In-process & Outgoing product quality assessment and Quality Management Systems.

•Maintain the QMS (ISO 9001:2000, 13485:2003)

•Perform Internal Audits in accordance with internal and external regulations.

•Provide customer feedback to OEMs for trending failures related to design and/or manufacturing defects. Drive associated Corrective Action

•Perform Supplier site audits (as required).

Regeneration Technologies, Inc. (RTI) – Alachua, FL 6/2004 – 8/2005

Quality Engineer

Provide leadership and support for Quality Review Board (QRB), CAPA, Manufacturing support, Validation, QC and Quality improvement projects initiated by Business Units.

•Review and modify (where appropriate) SOP’s, Work Instructions, Material Specifications (internal and external).

•Perform Supplier Audits as required by QMS.

•Provide backup for Quality Manager, Nonconforming Material Review (NCR) Coordinator and Quality Control Team Leader (in their absence).

Clairson Industries, LLC – Ocala, FL 1999 – 2004

Quality Manager

Responsible for all aspects of Quality Assurance for the Manufacturing and Tool building Departments. Oversee the validation and calibration programs, direction for 6 Quality Inspectors and 2 Quality Technicians. Responsible for the review of all returned goods and providing root cause analysis and corrective action. Assisted top management with direction for goals and objectives.

Education/Professional Affiliations/Training

ISO 14001:2004 Lead Auditor (QAI)

ISO 13485 & QSR Internal Quality System Auditor

Senior Member, American Society of Quality - CQM/CQA (expired) & CQT

Associate Science in Computer Engineering, Tampa Technical Institute, Tampa, FL

Florida National Guard Military Academy (Commissioned)

Retired Military Officers Association (1st Lieutenant)

References available upon request.

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