DENNIS HOLMES

**** ******** *****, *****, ** ****9

770-***-****

adw4wh@r.postjobfree.com

STERILITY ASSURANCE QUALITY ENGINEER / QUALITY MANAGEMENT SYSTEM MANAGER

Dedicated, proactive, and well-organized quality engineer offering solid experience in quality and sterilization engineering, root cause analysis, and quality management systems. Deliver quality controls and enhancements proactively addressing reliability issues and improving product quality, manufacturing flow, customer satisfaction, and bottom-line results. Able to handle multiple projects and meet deadlines under pressure. Self-motivated and able to work independently or in a team. Excellent interpersonal skills, able to communicate and collaborate effectively with co-workers at all levels. Risk averse forward thinking. Handling Audits and addressing 483’s. Class II and III med devices, combo devices a plus, MDSAP, EUMDR, ISO 13485. Post Market surveillance, CAPA, Implantable devices a plus.

Change Management · Start Ups / Turnarounds · Team Leadership / Motivation · Policy Development

Process Improvement · QC / QA · Vendor Relations · Cost Reduction · Ops Management · Risk Management (PFMEA) Analysis. QA Manager-5+yrs management experience in Med Device / Biotech / Combo.

Education:

Master of Arts – Organizational Management / Healthcare Administration – Ashford University – Clinton, IA

Bachelor of Science – Healthcare Management – Clayton State University – Morrow, GA

Associates of Science – Chemistry – Clayton State University – Morrow, GA

Awards:

Golden Key International Honor Society

Technical skills:

Microsoft Office Suite · WordPerfect · SPC software · Oracle · JD Edwards I · Minitab · Visio · Agile

PROFESSIONAL EXPERIENCE:

Club Car CO. (contract) Evans, GA., 11/2022-3/2023

Plant Manufacturing Quality Engineering.

Support product quality improvements for eliminating waste and meet organizational goals.

Subject matter expert and coach

Use of structural problem-solving tools: 5 Why, 9-step, A3, etc.

Manage and lead manufacturing quality techs (direct reports).

Implement process improvements etc.

Project manager for assigned projects.

Work to update documents and procedures, KPIs, and business initiatives.

Johnson and Johnson (Remote) Georgia, America, 8/2021 to 9/2022

EU MDR Specialist

Data collection

Report writer

UME (Unite Medical Enterprise) Augusta, GA., 5/2021 to 6/2021

Compliance Manager for project.

To apply compliance and SOPs for 510 (k) submission to project.

Validation and Engineering Group, Johns Creek, Johns Creek GA. 2/2021 to 5/2021 (Contract)

See below as same experience applied.

Principle Sterilization Specialist, Medtronic, Inc., Jacksonville, FL. 9/2019 to 1/2021 (contract)

A global leader in medical technology, services, and solutions.

Development, and improvement of new product lines, protocols and reports for sterilization validations. Ensured compliance to divisional, Corporate, ISO, EN requirements, and regulatory bodies. Led development, evaluation and approval of validation process and protocol formation. Created sterilization validation summary reports and analysis.

Achievements:

Conducted process sterilizations for new line production. Wrote technical reports for the sterilization process to be audited and submitted for approval. Worked with engineers for risk management (PFMEA) on product.

Validation and Engineering Group, Johns Creek, Johns Creek GA. 12/2018 to 5/2019 (Contract)

Validation & Engineering Group, Inc. is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, among other services in Puerto Rico and USA.

Validation Engineer

Executed validation protocols for major manufacturing processes: execution, final report writing and the review of calibration documentation. Provide oversight consultation for completion of new manufacturing lines concerning quality requirements, control systems such as: The Supervisory Control and Data Acquisition (SCADA) system that is a computer-based system used to provide process control and visualization for the production processes and to acquire and compile process data, the MES (Manufacturing Execution System) responsible for the collection and retention of process data utilized in the production of the electronic Device History Record (eDHR) associated with the finished good batches, as well coordinated, and managed daily activities such as spreadsheet validations, assisted in the approval/review & development of the protocol and procedures.

RES MED, Lithia Springs, GA 6/2016 to 5/2018

A world-leading connected health company with more than 5 million cloud-connected devices for daily remote patient monitoring, changes lives with every breath.

Sterility Quality Assurance Site Lead

Facilitated application of FDA, ISO, and procedures and protocols. Planned, coordinated, and managed daily activities of cross-functional staff consisting of Quality Control, Quality Engineers, and Sr. Quality Technicians. Integrated all functions necessary to complete projects to meet client requirements. Directed project development and implementation according to cost, schedule, and scope requirements. Provided oversight, development, implementation, and maintenance concerning quality assurance and control systems. Defined and specified application of standards, methods, and procedures for inspecting and evaluating precision, accuracy, and reliability.

Achievements:

Executed American assembly of mask lines through verification and validation of each line.

Created functioning labs for all CPAP units by establishing company testing labs on materials.

Controlled conforming and non-conforming material flow through the effective creation and execution of an innovative procedure.

Qualified and coached personnel for cGMP & cGDP on-boarding and FDA, ISO, and health regulations through application of an effective training program from corporate to personnel.

Gained complete asset control for calibrations and performed preventive maintenance throughout America by receiving education in Enterprise Asset Management Systems.

MEDTRONIC, Augusta, GA 3/2015 to 4/2016

A global leader in medical technology, services, and solutions.

Sterilization Assurance Engineer

Participated in support, development, and improvement of protocols and reports for sterilization validations. Ensured compliance to divisional, Corporate, ISO, EN requirements, and regulatory bodies. Led development, evaluation and approval of validation process and protocol formation. Created validation summary reports and analysis.

Achievements:

Delivered key contributions to numerous internal audits. Completed CAPAs from sterilization operations. Conducted three-day process sterilizations for customers production. Wrote technical reports for the sterilization process to be audited and submitted for approval. Worked with line engineers for risk management (PFMEA) on product.

ORCHID ORTHOPEDICS SOLUTIONS, Arab, AL 9/2014 to 2/2015

A world leading Medical Device Contract Design and Manufacturing Company

Sterility Quality Management Systems Engineer

Created, implemented and maintained quality management systems. Managed CAPA resolutions. Provided root cause analysis and implementation of corrective action for procedure related issues. Advanced training in quality awareness while ensuring compliance to divisional, corporate, ISO, and regulating bodies. Monitored performance and implementation of departmental facility audits. Produced and sustained company practices and procedures.

Achievements:

Improved and implemented approaches and processes for vendor relation and approved listings. Completed CAPAs and implemented procedures for manufacturing.

THERAGENICS CORPORATION, Buford, GA 2/2014 to 5/2014

A medical device company serving the cancer treatment and surgical markets.

Compliance Specialist, Contract

Organized and executed continuous process improvement initiatives concerning validations. Developed metrics providing data for process measurement and identified potential improvement indicators for new product sterilization. Participated and finalized CAPA, dose, particulate, and bioburden audits. Provided consultation on EtO with company from Gamma. Utilized hospital sterilizers for conversion processes. Strong collaborative person open to communication. Confident to be proactive and deliver but also smart to ask questions to improve knowledge as needed.

Achievements:

Ensured continuous monitoring and evaluation involving policies and procedures. Established the EtO (ethylene oxide) process for sterilization. Strong writer of SOP, training needs, CMC. Strong ability to read and comprehend regulatory language, and disseminate for needs and action.

SUNNY DELIGHT, Atlanta, GA 3/2012 to 1/2014

Beverage manufacturer.

Quality Control Analyst, Contract

Collected and analyzed data to evaluate robotic forklift vehicles utilizing statistical tools to produce reports concerning improvement. Completed detailed source inspections to meet client requests and created progress reports for Upper Management. Established procedures regarding human interaction with robots.

Achievements:

Provided personnel guidance ensuring compliance to quality standards and procedures. Implemented procedures for the robotic fork lifts working side by side with manual forklifts. Improved logistics of material parts for plant machinery.

STERIGENICS STERILIZERS, Smyrna, GA 3/2011 to 2/2012

Leading provider of solutions in sterilization and ionization supply chain management.

Validation Coordinator

Planned and coordinated sterilization validations and established validation protocols. Executed validation protocols and ensured compliance to divisional, corporate, ISO, and EN requirements. Reviewed and approved creation and development of customer protocols. Performed data collection and analysis and participated in CAPA audits.

Achievements:

Maintained data quality and integrity essential for validation records. Coordinated all sterilization processes.

CR BARD, Covington, GA 2/2010 to 11/2010

A leading multinational developer, manufacturer, and marketer of medical technologies in the fields of vascular, urology, oncology, and surgical specialties.

Quality Assurance Sterilization Engineer

Upheld quality assurance programs for sterilization validation activities. Updated applicable quality assurance procedures and reviewed pallet patterns, sterilization specification sheets, and cycle specification documents. Worked closely on process improvement projects while ensuring compliance to divisional, Corporate, ISO, and EN requirements. Upheld protocols and reports for sterilization validations. Supported cost savings programs.

Achievements:

Participated in process deviation failure investigations and management approval dispositions. Complied data for adoption of product lines.

Police Officer II, Union City, GA. Sept. 2008- Jun. 2009

Completed Georgia P.O.S.T. Council Training, November 21, 2008

Patrol (probation)

Completed arrest reports

Assigned duties

McDonald’s Corporation, Atlanta, GA. Jun. 2007- Sept. 2008

Assist Manager

Achievements:

Managed personnel of forty-six (46) employees

Reconciled bank accounts and administrative record keeping

Auditor and ordering of goods for store

Certification on food safety (Serve Safe)

Opening and closing of store

Porex Technology/Surgical, Fairburn, GA. Jun. 1986 – Mar. 2007

Quality Engineer

Achievements:

Completed 21 years of quality work in industrial and medical device technology through

Statistical process control

Develop, implement and maintain supplier quality program

Certified Lead auditor in ISO 9000: 2003 and 13485: 2003 Medical Device Mfg. (BSI)

Analyze processes for cost control

Protocol and validations performed

cGMP for manufacturing processes

Sterilization knowledge on EtO Gas (Ethylene Oxide Gas)

Knowledge of Six Sigma, Root Cause Analysis

Maintained Supplier Agreements and contracts

Participated in CAPA audits

Education

Ashford University, Clinton Iowa

Master of Arts in Organizational Management / Healthcare Administration (2010)

Clayton State University, Morrow Georgia

Associate of Science in Chemistry (1995)

Bachelor of Science in Healthcare Management (2000)

Computer Skills

Working knowledge of Excel, WordPerfect, Microsoft XP, Access, SPC software, Oracle, Word, JD Edwards I, Minitab, Visio, Agile

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