Quality Engineer Medical Device
Resume:
Thomas Duffy
Hilton NY, *****
( *******@*****.*** )
Introduction
I am part of a results-orientated culture creating the highest customer value, experienced in a regulated field with increasing levels of responsibly in product management, quality, engineering, development, maintaining and supporting product development, sustaining activities while providing product support and complaint handing in a customer facing role.
Highlights:
Complete understanding of the design control process in a regulated environment.
Working experience with ISO 13485, FDA 21 CFR Part 820, ISO 14971 used for design, manufacture, packaging, labeling, storage, installation and servicing.
Technical knowledge in development methodologies, design quality analysis, and project implementation.
Creating and revising SOPs, User Requirement Specs, Functional Requirement Specs, Design Specs, and Qualification plans
Provider of Level 3 support for handling of advance problems
Member of the complaint review cross functional team reviewing product complaints, product support escalations and company non-conformities.
Product and corrective action support in a customer facing role.
Software development, QA and testing experience
Creating and executing design verification and validation protocols.
Technical lead overseeing a team of personnel focused on technical issues, including software development, product releases, and engineering tasks
Supporting new product development activities at OEM partners
Providing internal staff with product and technical training of company products and services
Working directly with customers to understand difficult product or system concerns and to expedite customer satisfaction.
Focusing on product improvement, value engineering and cost reductions
Use appropriate statistical tools/methodologies to drive quality improvements in product lines.
Member of the change control board (CCB) approving and documenting ECN and DCN’s.
Strong Technical background
Complete understanding of the CAPA process
Experience with the development and implementation of a QMS and a quality plan.
Proficient in CRM systems, defect management tracking systems, test management tools and Microsoft Office suite.
Experienced Technical Product Specialist with a demonstrated history of working in the medical device industry.
Self-directed with the ability to develop, facilitate and gain consensus in a team environment
Additional Skills:
Project Management tools – JIRA
PLM tools - SAP, Oracle Agile, Microsoft Dynamics
Defect Management Tools - ClearQuest, JIRA
Test Management Tools - HP ALM Quality Center, TestFLO (JIRA)
Reliability software - Reliasoft, Minitab
Excellent technical and computer skills
Employment Experience
Carestream Health September 2016 – Present
Quality Engineer –
A contributor to new product development and manufacturing in areas of verification & validation of product requirements, regulatory requirements, specification development, measurable outcomes, hazard and safety analyses and other quality activities necessary to meet project objectives in the hardware/software/manufacturing arenas.
Delivering device design documentation compliant with FDA design controls and good documentation practices.
Customer facing role for the corrective action team
Provide Level 3 support for handling the most difficult or advanced problems.
Supporting new product development activities at OEM partners
Oversees timely and thorough investigation, root-cause analysis, completion, and effectiveness review of product design-related corrective and preventive actions (CAPA)
Creating, monitoring and maintaining Design History File, Device Master Record, BOM and Tech files
A key contributor to continuous improvement, where to improve, how to improve, and prevention orientated with a long term strategy.
Implemented and managed the reliability growth and reliability demonstration testing for new product development.
Material Review Board responsibilities for the evaluation and disposition of non-conforming product as well as creating and reviewing rework instruction
Review supplier compliance issues through questionnaires, scorecards and site visits
Active role in driving change management, and defining metrics.
Active role participating in the post production information collection process and post market analysis.
Lead and participate in risk assessments, FMEA’s
Member of the Complaint Review cross functional team reviewing product complaints, product support escalations and company non-conformities
Natus Medical
Sr. Product Engineer - Natus Medical May 2008 – August 2016
Engineering lead with our global contract manufacturers and suppliers with regards to all engineering and quality activities.
Contributor to new product development in a design quality engineering role.
Driving continuous improvement and value engineering initiatives on released products.
Creating, monitoring and maintaining Design History File, Device Master Record, BOM and Tech files
Creating and executing design verification and validation protocols.
Creating and performing process documentation including routing, work instruction, process flows and fixtures for assembly process.
Responsible for reviewing customer complaint investigations, analyzing investigation data for trends and communicating trends to appropriate personnel within the organization.
Provide operations input for supplier selection and process development activities
Project Manager for the RoHS and UDI compliance initiative maintaining on time completion date for implementation
Provide technical support to manufacturing, sales/marketing departments and customers
Lead for the post market surveillance team
Project Manager for hardware and software releases following the design control process.
Working knowledge of Kan-Ban replenishment systems
Experienced in internal, notified body and FDA audits. (BSI, Intertek, TUV)
Coordinate new product introduction and production support after transfer from design.
Startup experience working directly with startup partners assisting in the development and implementation of a QMS and a quality plan.
Interface with design, process, test, reliability and manufacturing engineering to solve product issues and production problems.
Member of the (MRB) Material Review Board responsible for the evaluation and disposition of non-conforming product as well as creating and reviewing rework instructions.
Served as an interface between Software engineering and Manufacturing to facilitate the implementation of software changes
Member of the team implementing the FDA mandated UDI identification.
Managed the sustaining engineering projects and prioritizes them based on company and customer needs.
Team member of the Risk Management Team, reviewing Risk Management Plan, Risk Analysis and post production information.
A key contributor of the cross functional team responsible for FDA 510k submissions collaborating with the regulatory team.
Working directly with customers to understand difficult product or system concerns and to expedite customer satisfaction.
Product and Quality Engineer, Technical Lead – Embla Systems June 2005 – June 2008
Responsible for the full product and quality engineering responsibility through entire design control and post launch process
Comprehensive knowledge of product development life cycle, risk assessment, and validation protocols.
Reviewed, qualified and documented sourcing changes on all components.
Conducted quality, statistical techniques, problem solving, SOP’s., work instructions, and other training
Authored and provided clear production assembly/test instructions to operations personnel to maintain efficient production.
Evaluated and improved processes in manufacturing systems.
Delivered medical device design documentation compliant with FDA design controls and good documentation practices
Created and maintained medical device Design History Files, Device Master Records and Bill of Materials.
Maintaining product performance and quality for existing products by leading and assisting with issues relating to CAPA's, non-conformities, customer complaints and manufacturing processes.
Created, maintained and updated written documents outlining and detailing planned goals, protocols, procedures, processes, solutions and results reports related to implementation and monitoring of quality assurance measures.
Identified and investigated failure modes to root cause
Recreation of customer complaints and system anomalies with software, hardware, or system performance
Global Hardware Support Manager - Embla Systems April 2003 – 2005
Proven track record working with senior management and department heads to assess and institute company-wide technical support policies and procedures.
Implemented remote access support tools.
Managed a team of integration and support personnel.
Managed and lead technical support departments in all offices worldwide.
Provided regular reports for management that measure the Quality of technical support service to the customer
Created and executed verification and validation test protocols, test plans and procedures.
Provided product validation in line with defined quality procedures and prepare appropriate documentation.
Assisted R&D and testing of new products and services to ensure issues are identified and resolved prior to customer release.
Managed and provided necessary departmental metrics to monitor performance and quality of products and services.
Interfaced closely with development teams to resolve customer issues.
Provided backup assistance for IT and support issues to ensure prompt resolution.
Implementation, review and supervision of field issue tracking system.
Oversees RMA issues that require shipping of products to customers.
Ensured that there is sufficient staff coverage in order to provide quick, responsive support.
Trouble shooting experience related to medical device products, consumables and accessories using proven measures of root cause analysis.
Provide technical support to manufacturing and sales/marketing departments and customers
Educational Background:
AAS, SUNY ECC, Williamsville
Enrolled and Working toward BS, Computer Science, Buffalo NY
Villanova University – QE Certification Path, Essentials in IS Security, ISTQB Software Testing Capstone, Essential in Software Testing
Currently enrolled in classes for certification through ASQ, American Society of Quality
Completed Root Cause Investigation for CAPA, Weaver Consulting
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