Quality Engineer Product
Resume:
Dennis Holmes
*************@*******.***
**** ******** *****, *****, ** 30809
Professional Summary:
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, MES (Manufacturing Execution System) testing/validations, CAPA, Implantable devices a plus.
Core Competencies:
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
Ashford University, Clinton, IA 2010
Master of Arts in Organizational Management / Healthcare Administration
Clayton State University, Morrow, GA
Bachelor of Science in Healthcare Management 2000
Associate of Science in Chemistry 1995
Computer Skills:
Working knowledge of Excel, WordPerfect, Microsoft XP, Access, SPC software, Oracle, Word, JD Edwards I, Minitab, Visio, Agile
Professional Experience:
Boehringer Ingelheim, Athens, GA Jul 2023 – Present
Validation Specialist
Responsibilities:
Validation of walk-in freezers, sub-freezers, refrigerated truck and processing tank equipment
Conducted comprehensive requalification of autoclaves, including performance qualification, operational qualification and installation qualification.
D0eveloped comprehensive protocols for various processes, including testing, validation, and operational procedures.
Provided training and guidance to team members on protocol and report writing best practices.
Managed document control systems to organize and track protocol and report versions.
Coordinated with cross-functional teams, including engineering, construction, and operations, to ensure seamless commissioning processes.
Managed project timelines, resources, and budgets to ensure timely completion of commissioning activities.
Prepared comprehensive commissioning reports and documentation.
Ensured efficient operation of the packaging line by troubleshooting and resolving mechanical issues.
Conducted regular inspections and preventive maintenance to minimize downtime.
Club Car CO., Evans, GA Nov 2022 – Mar 2023
Plant Manufacturing Quality Engineering
Responsibilities:
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).
Implemented quality improvement initiatives that reduced packaging defects.
Implemented Manufacturing Execution System (MES) to improve production output.
Led a team in conducting root cause analyses for quality issues, resulting in improved production efficiency.
Developed and executed validation protocols for new packaging equipment installations.
Project manager for assigned projects.
Work to update documents and procedures, KPIs, and business initiatives.
Avanos Medical, Atlanta, GA (remote) Apr 2021 - Jul 2021
EU MDR Specialist
Responsibilities:
Developed and maintained comprehensive documentation for data collection processes.
Collected and analyzed clinical data to support EU MDR and FDA submissions.
Maintained accurate and up-to-date records of all data collection activities.
Developed comprehensive reports, including Clinical Evaluation Reports, Post-Market Surveillance reports, and Periodic Safety Update Reports.
Created clear, concise, and detailed documentation for regulatory submissions.
Oversee and manage all aspects of packaging operations for medical devices, ensuring adherence to EU MDR standards.
Develop and implement packaging processes and procedures that comply with regulatory requirements and industry best practices.
Conducted thorough research to ensure compliance with current and emerging EU MDR standards.
Cleaning and sterilization data collection for report
Johnson and Johnson (Remote), Atlanta, GA Aug 2021 – Sep 2022
EU MDR Specialist
Responsibilities:
Collected, organized, and maintained clinical and non-clinical data required for EU MDR submissions.
Utilized electronic data capture systems and databases for efficient data management.
Ensured accuracy, integrity, and security of all collected data.
Conduct regular audits of packaging lines to ensure compliance with EU MDR and other regulatory standards.
Collaborate with cross-functional teams including quality assurance, production, and regulatory affairs to resolve packaging-related issues.
Developed and maintained quality control documentation, including SOPs and inspection reports.
Conducted thorough research to ensure compliance with current and emerging EU MDR standards.
Cleaning and sterilization data collection for report
UME (Unite Medical Enterprise), Augusta, GA May 2021 – Jun 2021
Compliance/Packaging Specialist
Responsibilities:
To apply compliance and SOPs for 510 (k) submission to project.
Implemented quality assurance processes and procedures to ensure compliance with manufacturing standards and regulations.
Conducted inspections and audits to monitor product quality and identify areas for improvement.
Developed and maintained quality control documentation, including SOPs and inspection reports.
Developed and implemented compliance programs that ensured adherence to FDA regulations and ISO standards for packaging operations.
Led cross-functional teams in the successful implementation of packaging line validation projects.
Medtronic, Inc., Jacksonville, FL Sep 2019 - Jan 2021
Principle Sterilization Specialist
Responsibilities:
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.
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. Implemented automation lines (software, water (RO), electrical, robotics, etc.) through IQ, OQ, and PQ processes for production and packaging of product. Accelerated project management goals.
Managed packaging line projects from conception to completion, ensuring compliance with regulatory standards and operational efficiency.
Implemented risk management strategies to identify and mitigate risks associated with packaging processes and materials.
Conducted risk assessments and developed risk mitigation plans to ensure product safety and regulatory compliance.
Johns Creek, Johns Creek, GA Dec 2018 - May 2019
Validation and Engineering Group
Responsibilities:
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.
Executed validation protocols for major manufacturing processes: execution, final report writing and the review of calibration documentation.
Assisted in the setup and calibration of packaging equipment for new product lines, ensuring compliance with specifications.
Documented packaging processes and maintained records of equipment maintenance and calibration.
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.
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