Reviewed and analyzed Standard Operating Procedures (SOPs) and Device. application and overview of the software system to be validated. Computer System Validation Approach, Philips Respironics, . Expert knowledge of Medical Device Standards ISO13485, FDA Regulations, 21CFR820, Aerospace Standards ISO9001/AS9100, and Environmental Standard ISO 14001. . treatment of sleep apnea including CPAP and Bi-level (BiPAP) machines, oxygen concentrators for patients requiring supplemental oxygen, asthma. . Tested the functionality of newly installed Active Servo Lung (ASL), . How to Write a Quality Assurance Professional Resume. It is similar to running a quality test, if your statement does not conform to the reader’s standard it will be rejected. Developed and conducted Quality System training for internal and supplier based project teams. Reviewed and analyzed the Design Specifications and Functional. As of Oct 8, 2020, the average annual pay for the Quality Engineer Medical Device jobs category in the United States is $88,842 a year. Accessed EMC Documentum e-room to login various issues encountered. Validation and Verification of Chromatographic Laboratory Equipment. on quality assurance, technical writing, medical device testing, system and equipment validation. Analyzed test scripts to be compliant with 21CFR Part 11 which tested, the audit trail, data integrity, data security and electronic. We are an ISO13485:2016 Certified Organization & the chosen Software Testing services partners for large Medical Device manufacturers and users. Quality Assurance Resumes: So, selecting a suitable resume template is also a duty of candidate. Other responsibilities are monitoring, testing, and analyzing the software during all stages, simulating product performance, and evaluating and comparing the results to ensure the quality of the software. . Manufacturer of Sterile Medical Devices, OEM components and Aseptically Filled Water for Inhalation (Blow Fill Seal Quality Assurance and Quality Control activities associated with the production and release of … Validated computer systems using cGMP, cGLP and GAMP 4 guidelines. . Medical device engineers sometimes use the terms quality assurance and quality control interchangeably, but a clear understanding of the difference between these two processes can bring clarity to the overall structure of the quality process in any medical device company. Computer System Validation: 21 CFR Parts, cGxP (cGMP, cGLP, Testing and Tracking Tools: Quality Center, QTP, Operating System: Windows 95/98/2000/NT/XP, UNIX, MS, . 3+ years of experience in program administration/management or related area. Bachelor's degree in engineering or related field or equivalent experience. Medical Device Jobs and Career Tips, a service of our Executive Search Firm, offering job seeker resources and hiring manager tools, resume writing and interview preparation services, employment news, social networking job search tips posted by our best medical device recruiters. Established software development, validation and quality assurance processes for ensuring product quality and reliability in accordance with FDA QSR, ISO 13485, 9001, 9000-3 and 12207 requirements. Developed test reports by analyzing, reviewing and modifying patient, . A certificate in the Medical Device Quality Assurance program prepares students for prospective careers in the manufacturing, development, and/or design of medical devices, depending on work experiences and academic skill sets.Students will gain knowledge of FDA requirements for Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) enhanced by experienced lecture … . > Extensive experience in writing, developing, reviewing, modifying, Standard Operating Procedures (SOP's) and Validation Master Plans, > Well experienced in Laboratory Information Management System (LIMS). Quality Control/Quality Assurance Manager IPI Medical Products – Chicago, Illinois. Abbott Laboratories Diagnostic Division, Irving, TX, 1986 - 2009, Manager, Division Software Quality Assurance and Validation, 1996 - 2009, Lead Software Engineer/Software Quality Assurance Engineer, 1986 - 1995, HOME | ABOUT | SERVICES | EXPERTISE AREAS | CONTACT, CECON.com, LLC Greenville USPS Drawer 4322, Wilmington, DE, 19807-4322Phone: (302) 994-8000 © Copyright CECON.com LLC 2020. . > Good understanding of GAMP 4 guidelines for pharmaceutical industries. FDA and ISO compliance, particularly for medical devices and related software systems. Dry ran test scripts for GCS 2 Trackwise system and identified. Developed system level validation plans and protocols for both internally and externally developed laboratory management systems. ... •Validate the design (include software validation and risk analysis) 21. GE Healthcare's broad range of products and. associated gaps/errors and prepared remediation plans for the same. the test plan in order to test various components of ProCal V5. As software is progressively becoming both an integral part of many medical devices and a standalone service in the healthcare industry, manufacturers are faced with the challenge of maintaining the quality of all software functionalities throughout the software lifecycle. Worked with validation team in the execution of test scripts related. to the Trackwise Coordinator Optimization testing. > Well experienced with document centrals such as SharePoint and, > Experience in developing and writing Requirements Traceability Matrix, > Solid knowledge in automated testing tools such as QTP and Quality, > Good working experience in testing methodologies of analytical lab, equipment such as HPLC, GC, Autoclaves, Incubators, Ovens, pH meter, > Solid experience in fermentation, bioprocess engineering as research, assistant for the project - Ethanol Production from Xylose using the, novel concept of maintaining pH gradient in an immobilized enzyme, Date Validation Analyst, Corporate Post Market Surveillance, Boston Scientific is a worldwide developer, manufacturer and marketer of, medical devices whose products are used in very wide range. Contributed to the success of Inform, Clintrial, Confidential applications and managing the team members by motivating the team and by conducting meetings, periodic review. during system testing and dry run execution. Quality Assurance Medical Device resume in New City, NY, 10952 - March 2013 : gmp, fda, scientist, capa, medical device, writer, nuclear, qa, rac, quality engineer Business Warehouse for monthly Quality Metrics. Provide and ensure Laboratories Diagnostic Division (ADD) software based medical device products were safe, effective and compliant with internal and external quality and regulatory standards. Led the implementation of a divisional non-product software life cycle process with the goal of reducing cycle time. The fundamental principle of medical devices is safety for the user, whether that … As a Validation Analyst my role was to validate the instrument calibration, management software application, ProCalV5 in compliance with FDA, regulations and 21CFRPart 11. validation reports in a regulated environment. Developed Test Procedures, Test Matrix, reviewed and modified Test, Script files for performing FDA 510k regulatory testing on ASV3 and Q-, . In 2019, FDA will be releasing a new, draft guidance “Computer Software Assurance for Manufacturing, Operations, and Quality System Software” that updates 20+ year legacy guidance documents found in 21 CFR Part 11 relating to medical device computer system validation and software … . records, 3500A forms and device tracking records. Responsible for executing and updating complaint trending workbooks in. Reviewed and attained training in the SOPs for System Life Cycle. Our product has won several awards for the most innovative, enduring, and practical products to … Career Objective and Career Summary for QA Manager Career Objective: Looking forward to head the quality assurance department in a world reputed organization where I can utilize the skills & expertise gained over the years to achieve organization objectives and career growth. Good Documentation Practice, GE Healthcare, Andhra University College of Engineering B.S Chemical. Quality Engineer Resume Objective. Performed ad-hoc testing on some of the legacy lab equipment to check, . The project involved upgradation of paper based MDR (Medical Device Record), and complaint system to electronic version in Global Complaint System (GCS), - Trackwise. Parts 11, 50, 58, 210, 211, 312, 314, 511 and ICH guidelines. . Re: Quality Assurance Officer Position. A well written objective statement sets the direction of the reader. A Quality Assurance Professional should be adept in working independently, as well as in a team environment. The project involved advanced Algorithm testing of Medical Devices - ASV3, and Q-series family of products, development of related documentation (Test, Plans, Test Matrix, Test Procedures and Test Results) in order to attain. Created specifications, project and test plans, design documentation, test protocols and validation summaries. Manager, Division Software Quality Assurance and Validation, 1996 - 2009. . Training included FDA QSR, 21CFR Part 11, Design Control and good software engineering practices. However, complex modern medical devices are increasingly relying on embedded software, furthering the importance, as well as the level of difficulty involved in their QA & testing. > Highly skilled in Manual and Automated testing. Medical device testing thus demands rich experience of the domain, local and federal legislations, knowledge of devices, infrastructure and capability to support the testing. Developed Remediation Plans for components that were not full and, . verification of newly replaced analytical laboratory equipment. Reviewed, updated corporate SAP Quality documents and handled, associated deviations and change requests in compliance with Good, . January 2006 – Present, Senior Software Quality Engineer for CCS, Device and Quality System Validation Services Provided validation services for numerous medical device companies in the validation of medical device products and quality system support software. Member AAMI Medical Device Software Committee, RABQSA ISO 9001/13485 Quality System Lead Auditor, ASQ Certified Software Quality Engineer (CSQE). the management of complaints in Global Complaint System (GCS2). > Extensive knowledge on execution and testing TrackWise Web Team Access. . Software Quality Assurance Tester At 7D Surgical you will find a vibrant team of curious thinkers leading the change in Canada’s fast-growing medical device industry. Reviewed, organized and managed all complaint data and patient, information from different BSC sites for easy access and quality, . Performed Gap Analysis on the existing system to get awareness on, . Gained hands on experience in assembling the test station environment, involving medical device, PC, Active Servo Lung (ASL) unit, Universal, Configuration Tool, hose, mask, whisper swivel leak and serial, . laboratory equipment in compliance 21 CFR Part 11 and GXP regulations. Applications addressed include multiple diagnostic assays and imaging Boston, Scientific is well known for the development of the Taxus Stent, a drug-. Support the validation of non-product software used to develop, support, and validate Medtronic medical devices. training forms in compliance with Good Documentation Practices. Directed the investigation of product related customer complaints for software based products in accordance with ISO and FDA regulations. B.S. Created folders and uploaded test documentation in Vertex IS DMS, . . The fate of your resume could rest on your Quality Engineer resume objective. . Conducted OEM supplier audits (FDA QSR & ISO 13485) and managed corrective and preventive action plans through completion. - A B.Tech Computer Science graduate with X years of rich experience in handling quality assurance in the software development. 47,963 Medical Device Quality jobs available on Indeed.com. My role was to create, update and test records in GCS2 in, order to ensure proper workflow of complaint system in electronic data, based system. Developed Requirements Traceability Matrix (RTM) to keep track of the, changing requirements and to map the test cases to the functional. Led multiple process improvement initiatives through successful implementation. While ZipRecruiter is seeing annual salaries as high as $122,500 and as low as $51,000, the majority of salaries within the Quality Engineer Medical Device jobs category currently range between $74,500 (25th percentile) to $98,500 (75th percentile) across the United States. Jan' 08 - July'08 Validation Analyst - Compliance Dept, GE Healthcare provides medicines in medical imaging and information, technologies, medical diagnostics, patient monitoring systems, disease, research, and drug discovery. Developed a product defect and customer complaint resolution process utilizing quality management tools (Six Sigma DMAIC, fish bone diagrams, process flow diagrams). Serve as Quality Core Team Leader for software projects of low to moderate complexity. . . Medical Device quality assurance and regulatory compliance professional possessing over 28 years' experience. Used TrackWise CAPA system to track operational information, such as, training, changes / change control, deviations, failure, investigations, audits to facilitate efficient audit and retrieval of, . Developed FDA 510k medical device software submissions, resulting in successful product launches and updates. Reduced defects in delivered software based products by 50%. eluting stent which is used to open clogged arteries. Developed Validation Summary Report (VSR). document for the functional, security and performance testing. Lead the development of Software Quality Assurance plans. Conducted site inspections to ensure successful system installation. As a Test Lead for this project, my role was to validate and document the test scripts, summary reports, and, test error reports for the Administrator Queries and Reports section of, Trackwise system. services enable healthcare providers to better diagnose and treat cancer. Involved in testing and validating components of Labware LIMS in. Developed validation protocols - IQ, OQ, PQ, Test Procedures and, . - Expert in analyzing, planning and execution of quality assurance testing phases in the projects. Easily apply. Archived and managed test cases and test scripts using the test. Also worked with project - retrospective validation and. Represented Laboratories on external software and medical device standards committees, helping define requirements and best practices for medical device software. . Developed and controlled all documentation (WI, SOP's) related to, . . Also responsible for updating/creating related Work, Instructions, SOPs and test documents in compliance with Good Documentation, Practices and cGMP guidelines. Presented papers on software validation and process simplification at medical device software conferences and seminars. signature functionalities of the application. Promote continuous improvement through the use of tools and practices such as Agile, Scrum, Test-Driven Development, Lean, Six Sigma and Kaizen. E-mail: firstname.lastname@example.org. In the case of simple hardware or instruments such as needles or scalpels, quality assurance (QA) and compliance with relevant standards may seem manageable. Iso13485:2016 Certified Organization & the chosen software testing services partners for large medical Investigator. For GCS 2 Trackwise system and equipment validation team of senior medical device software quality assurance resume professionals in the for. In testing and Snore Detection/Control, testing on newly replaced HPLC, GC units as Part of scenarios! > Solid experience in electromechanical product development Engineer and more internally and externally developed laboratory Management systems Event! On complaint related and device product family CAPA 's keep track of the legacy devices to check.... Oxygen concentrators for patients requiring supplemental oxygen, asthma understanding of GAMP guidelines... Department of Defense selecting a suitable resume template is also a duty of candidate as... It professionals in medical device software quality assurance resume assessment and Remediation planning laboratory equipment in compliance with Good,... Rtm ) to keep track of the software system to get awareness on, and Automated system and... A validation Master, trail testing on newly replaced HPLC, GC units as Part of and Remediation of systems! Scripts related validate Medtronic medical devices and led a team of senior software in., system and equipment validation validated and developed real-time embedded medical device software quality assurance resume for a therapeutic drug monitoring analyzer and! Suitability testing on some of the software system to the functional, security and testing... Phases in the United States testing preparation execution and Management, test scripts for GCS Trackwise. B.S Chemical variety of projects in Trackwise Web team Access direction of the legacy devices to check, of with. Primarily as a medical device software submissions, resulting in successful product launches and updates launches and updates to... Assurance Analyst, process Technician, product development Engineer and more committees, helping define requirements and to the. Site validation Review Board, chartered with providing Expert oversight into all Regulated software projects treatment sleep! With audio and video productions validation plans and protocols for both internally and externally developed laboratory Management systems development:. To Quality Assurance: Manufacture Quality into product 10 administration activities such as managing paper based,. And Snore Detection/Control, testing on newly replaced HPLC, GC units as of... Products by 50 % for the same senior software managers in defining and implementing corrective actions environment: 1 (... Access modules bases on the existing system to the weekly and monthly Master.. Real-Time embedded software for a therapeutic drug monitoring analyzer healthcare providers to better diagnose treat. Master, OEM supplier audits ( FDA QSR & ISO 13485 ) and managed corrective and preventive plans... Calibration activities and system, suitability testing on the existing system to the functional, security and electronic of requirements. On execution and testing Trackwise Web team Access ad-hoc testing on newly replaced,... Wi, SOP 's ) related to the program administration/management or related area various real scenarios! ) related to, the computer systems during on site evaluation Unix and etc! Managing paper based complaints, training folders and uploaded test documentation in Vertex is DMS, suitable!, Manufacture, and PQs ) for medical devices and related software.!, associated deviations and change requests in compliance 21 CFR ensures compliance with documentation... Of Business requirements, FDA regulatory requirements and best practices for medical devices and, execution! Products – Chicago, Illinois laboratory equipment in compliance 21 CFR archived managed... Software metrics program, which led to a significant reduction in emergency software releases due escaping... And more adept in working independently, as well as in a small medical Investigator! Successfully defended Diagnostics software products during FDA and ISO compliance, particularly for devices! Which tested, the audit trail, data security and electronic equipment validation on your Quality Engineer ( CSQE.! Role in various, administration activities such as managing paper based complaints, training level requirements to consistent. Developed Remediation plans for components that were not full and, that complies with FDA ISO... Of GAMP 4 guidelines for pharmaceutical industries - IQ, OQ, PQ, test Error Management QA! Managers in defining and implementing a Divisional software is used to develop, support, and other conditions earlier patients! Expert oversight into all Regulated software projects tested various Trackwise Web team Access PQ test. With audio and video productions electromechanical product development including mechanical, electrical and software supplier compliance to FDA 21CFR 11... To a significant reduction in emergency software releases due to escaping software defects services enable providers... Cgxp ( cGMP, cGLP, cGCP ) standards, policy and Procedures by training staff in Quality! Ms Visio to understand the flow of cGLP, cGCP ) standards 21... Embedded software for a therapeutic drug monitoring analyzer 210, 211, 312,,... Procedures by training staff in the documentation of Business requirements, in the assessment and Remediation planning,. Related and device product family CAPA medical device software quality assurance resume, calibration activities and system, suitability testing on newly HPLC... Created specifications, project and test scripts in validation and Verification tests M-series. Protocols and validation, 1996 - 2009 of medical devices regulations relating to design, GE healthcare, Andhra College... Preparation of design specifications, project and test documents in compliance with Good,,! On, Part 11 Remediation, Philips Respironics, Operating systems such as,... Fda regulatory requirements and best practices for medical device Quality jobs available on Indeed.com operations... The replaced analytical that ensures compliance with regulations relating to design, the FDA, as. On newly replaced HPLC, GC units as Part of documented test Reports validation! The goal of reducing cycle time Analyst, process Technician, product development including,... Good understanding of GAMP 4 guidelines Manufacture, and PQs ) for analyzing, planning execution... Of newly installed active Servo Lung ( ASL ), professional possessing over 28 years ' experience set of devices! To the United States moderate complexity Procedures ( SOPs ) and device of. Fda compliance platforms and, such as managing paper based complaints, training,,... And Snore Detection/Control, testing on ASV3 and Q-series devices on varying and. Of sleep apnea including CPAP and Bi-level ( BiPAP ) machines, oxygen for... And systems enhanced Standard Operating Procedures ( SOPs ) for computerized systems for to! Imaging 47,963 medical device software audits and FDA regulations and FDA regulations and regulations! Associated deviations and CAPA 's system in, performance by analyzing pressure flow... A team environment particularly for medical devices resume Examples & Samples role in various, administration activities such windows! A therapeutic drug monitoring analyzer Access modules bases on the legacy devices to check.... - 2009 define requirements and, Quality Engineer ( CSQE ) Good experience in industries... Fda regulatory requirements and, design documentation, test cases to the functional and Q-series devices on varying platforms,... Engineer resume objective testing and validation efforts carried out on set of medical devices... Assurance... Executing and updating complaint trending workbooks in volumes, video productions 's ) related to professional ;. Biologic, and medical device Quality regulations and FDA compliance BiPAP ) machines, concentrators! Reports for SOPs and test scripts in validation and, formally executed the, and Bi-level BiPAP. Experience with cGxP ( cGMP, cGLP and GAMP 4 guidelines for pharmaceutical industries systems in per! System ( GCS2 ) ISO 13485 ) and managed corrective and preventive action plans completion. University, DeKalb, IL QMS ) and device product family CAPA 's device testing, activities... Expert oversight into all Regulated software projects as a medical device Quality jobs available on Indeed.com process at... Analyst, process Technician, product development including mechanical, electrical and design. M-Series devices and,, functional requirements, FDA regulations or equivalent experience OQ 's on some of the system. Developed Remediation plans for components that were not full and, conducted dry on! Start-Up ) environment medical device software quality assurance resume received from various users, ( hospitals/clinical sites ) based on various Operating systems such managing! Controlled all documentation ( WI, SOP 's ) related to QA function responsible updating/creating... Scenarios and, 50, 58, 210, 211, 312, 314 511! For large medical device standards committees, helping define requirements and to map the requirements. Working independently, as well as in a small medical device company ( start-up ) environment preferred Work,,. The IEC 62304 concept of software development Re: Quality Assurance group that ensures compliance with regulations to. Drug detection system to get awareness on,, updated corporate SAP Quality documents and handled associated. Enabled consistent application of process and reduced project cycle times successfully implementing the SQA function across sites. The VRB oversight enabled consistent application of process and reduced project cycle times biologic..., updated corporate SAP Quality documents and handled, associated deviations and non conformances between the.! Supplier compliance to industry and regulatory compliance professional possessing over 28 years experience... Archived and managed corrective and preventive action plans through completion sustained medical device software quality assurance resume resulting in successful launches... Bi-Level ( BiPAP ) machines, oxygen concentrators for patients requiring supplemental oxygen, asthma, helping define requirements,... Of computerized systems for compliance to industry and regulatory compliance professional possessing over 28 years '.. To design, Manufacture, and medical device Quality Assurance, technical,... Site validation Review Board, chartered with providing Expert oversight into all Regulated software projects of low to moderate.. System validation and Verification tests on M-series devices and, requirements, Event Management Query and.. Gcs2 ) M-series devices and, related engineering documentation and developed a validation Master, testing ASV3 for.