Document Control Quality Assurance

Keith J. McSally

*** ***** **, *. *********, MA *2760 Tel: 774-***-**** Email: ********@*****.***

SUMMARY

Experience within the Engineering Industry (Application and Construction) and within the Medical Device Manufacturing Industry. Duties included Hardware/Software Implementation, Document Control, CAPA requests and investigation and resolution verification, Testing and Validation and related QA, writing and reviewing Engineer Procedures/Test Procedures/Plans, supporting engineer teams, Document Control activities and customer/sub-supplier relations including customer documentation management and distribution, QA Inspection, Machine Operation, and assorted Clean Room operations.

Familiar with International Mechanical Code IMC 2012, ISO 9001 Quality Management System, 10 CFR 50 Appendix B Quality Assurance for Nuclear Power Plants and Fuel Reprocessing Plants, ISO 13485, Project Life Cycles, QMPs, Manufacturing Processes. Providing management support for Project Planning, Finances, Financial Statements and Balance Sheets.

PROFESSIONAL EXPERIENCE

ThermoFisher – Plainville, Ma.

Quality Document Control Specialist Sept 2023-Mar 2025

Quality Document authoring, issuance, review of other authors, and final review of completed records for GDP and final storage of Quality documents.

Assist it in audits, providing any documentary or historical information for Eng. Review/Corrections documentation to accurately assess practices and procedures, internally or externally (audit wise).

Team Training.

Use of ThermoFisher LMS.

Extensive use of Office, Excel, Access.

Extensive use of Documentum (D2).

Coordinate with teams and SMEs for review and approval of Manufacturing procedures.

Siemens Healthineers – Edgewater, Ma.

Quality Professional Sept 2021-Aug 2023

Quality review of policy and procedure documents before release to Siemens Engineers across continents to ensure they meet Siemens and Federal standards and Legal requirements.

Assist it in audits, providing any documentary or historical information to accurately assess practices and procedures, internally or externally (audit wise).

Gilbane Building Company – Providence, RI

Document Review Engineer May 2019-Jul 2020

Team member on the Gilbane Co IDC (Interdisciplinary Document Coordination) team. “IDC is a preconstruction service designed to identify, track and communicate construction document coordination issues to the design and project teams prior to procurement and before construction. By taking a project’s nearly complete construction documents (plans, specifications, and bulletins) and comparing/contrasting them to one another, we can easily identify coordination issues between construction disciplines.” Review construction drawings and compare between disciplines (electrical, structural, mechanical, architectural, civil, etc.) and requirements documents, identifying possible problems between disciplines, verifying requirements implementation and missing requirements.

NeedleTech Products, Inc. – N Attleboro, MA

Machine Operator Dec 2017-May 2019

Machine and process a wide range of custom specialty needles, cannulas, stylets and similar steel components, along with advanced molding capability to conform to customer specifications in accordance with cGMP.

Ensure manufactured products are within Quality Control limits,

Smith & Nephew – Mansfield, MA

QA Inspector Feb 2016-Dec 2017

Inspect packaged manufactured medical components to ensure customer requirements and appropriate standards have been satisfied while observing cGMPs

Ensure all documents meet GDP standards and direct team to provide adequate coverage to various product lines

Invensys (Currently: Schneider Electric) – Foxboro, MA

Application Engineer II Sept 2002 – Aug 2014

Applying/Customizing propriety software to implement Automated Controls per customer requirements from design to implementation, testing, and finally to delivery

Large Operational Database management (primarily Access), Query Design, SQL, Extensive Reports, Excel Integration, Visual Basic programming, various scripting

Engineering Document writing and review, QA Activities, Customer Interface, Testing, and customizing propriety software

United States Army (E-5, Sergeant) Jun 1989 – Dec 1998

Squad Leader/Assistant Shop Foreman

EDUCATION

NORTHEASTERN UNIVERSITY Boston, MA

Master’s of Science in Engineering Management, Sept 2012

UNIVERISTY OF MASSACHUSETTS, DARTMOUTH Dartmouth, MA Bachelor of Science in Computer Information Sciences, June 2002

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