medical device software quality assurance resume

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Reviewed and analyzed the Design Specifications and Functional. FDA 510k clearance on the above mentioned devices. Program Manager, Medical Devices Resume Examples & Samples. > Profound experience with cGxP (cGMP, cGLP, cGCP) standards, 21 CFR. Quality Control/Quality Assurance Manager IPI Medical Products – Chicago, Illinois. 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. . Developed Test Plans, Test Cases, and Test Scripts and executed the, . Member AAMI Medical Device Software Committee, RABQSA ISO 9001/13485 Quality System Lead Auditor, ASQ Certified Software Quality Engineer (CSQE). 47,963 Medical Device Quality jobs available on Indeed.com. . Experience in a small medical device company (start-up) environment preferred. training forms in compliance with Good Documentation Practices. Led multiple process improvement initiatives through successful implementation. Quality Engineer Resume Objective. - Hands on working experience on various operating systems such as windows, Linux, Unix and Solaris etc. Established system level requirements to ensure consistent and sustained compliance. Validated and developed IQ, OQ's on some of the replaced analytical. Presented papers on software validation and process simplification at medical device software conferences and seminars. Developed Test Procedures, Test Matrix, reviewed and modified Test, Script files for performing FDA 510k regulatory testing on ASV3 and Q-, . Its products includes devices for the diagnosis and. Developed system level validation plans and protocols for both internally and externally developed laboratory management systems. - A B.Tech Computer Science graduate with X years of rich experience in handling quality assurance in the software development. Developed a product defect and customer complaint resolution process utilizing quality management tools (Six Sigma DMAIC, fish bone diagrams, process flow diagrams). Worked with validation team in the execution of test scripts related. Tested the functionality of newly installed Active Servo Lung (ASL), . . > Good experience in handling change controls, deviations and CAPA's. . validation reports in a regulated environment. > Diverse experience in biotech/pharmaceutical industries with emphasis. . . Notified and logged in any deviations and non conformances between the, . testing and validation efforts carried out on set of medical devices. Validated computer systems using cGMP, cGLP and GAMP 4 guidelines. on quality assurance, technical writing, medical device testing, > Solid experience in documentation for all aspects of computer system, validation (CSV), Installation Qualification (IQ), Operation, Qualification (OQ), Performance Qualification (PQ) and final. Installed and ran computer systems during on site evaluation. Conducted site inspections to ensure successful system installation. SUMMARY: Professional experience with Validation of Software, Computer Systems/Testing used in Laboratories, Clinical, Pharmaceutical/ Medical Devices and Biochemical Industries. A winning resume should showcase the candidate’s ability to ensure that projects run smoothly and goals are completed in compliance with rules and regulations. Analyzed and assisted in the documentation of business requirements, . Medical Device quality assurance and regulatory compliance professional possessing over 28 years' experience. Conducted system testing based on various real life scenarios and. Performed Validation and Verification tests on M-series devices and, . Led a team of senior IT professionals in the assessment and remediation of computerized systems for compliance to FDA 21CFR Part 11. > Experience in Validation procedures for Clinical Trials. Optimizes Quality Assurance standards, policy and procedures by training staff in the Quality Management System (QMS) and implementing corrective actions. Reviewed and analyzed Standard Operating Procedures (SOPs) and Device. laboratory equipment in compliance 21 CFR Part 11 and GXP regulations. Successful resume samples for this job highlight responsibilities such as making sure products meet client and industry requirements, training other employees, updating defects databases, and separating defect items. Our product has won several awards for the most innovative, enduring, and practical products to … 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. . Involved in testing and validating components of Labware LIMS in. Developed and enhanced Standard Operating Procedures (SOPs) for. 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. Re: Quality Assurance Officer Position. Performed ad-hoc testing on some of the legacy lab equipment to check, . Boston, Scientific is well known for the development of the Taxus Stent, a drug-. Development process for medical device software that complies with FDA and ISO regulations. Significantly reduced software development cycle times and defects. A well written objective statement sets the direction of the reader. Serve as Quality Core Team Leader for software projects of low to moderate complexity. Skills shown on sample resumes of Quality Auditors include conducting hourly inspections on parts to ensure that the product is maintaining conformity, and performing dock audits to prevent non-conforming products from getting to the customer. > Solid experience in documentation for all aspects of computer system. accessing, testing and handling ProCalV5 application. . 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. . 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 … Created flow charts using MS Visio to understand the flow of. eluting stent which is used to open clogged arteries. Developed Test cases, Test Scripts, Test Summary Reports based on the. Lead QA Tester, Software & Systems Group, 8/08 to 3/12 QA Tester, Software Solutions Group, 8/04 to 8/08 Promoted to serve as lead QA tester, overseeing quality-assurance testing and teams for client software and systems development projects. > Highly skilled in Manual and Automated testing. Manufacturing, pharmaceutical, biologic, and medical device operations. Reviewed, updated corporate SAP Quality documents and handled, associated deviations and change requests in compliance with Good, . 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. How to Write a Quality Assurance Professional Resume. 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. Testing Preparation Execution and Management, Test Error Management. Do not increase your burden by searching for the best resume … 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. Tested various Trackwise Web Team Access modules bases on the design, . Analyzed the test requirements, FDA regulatory requirements and, related engineering documentation and developed a Validation Master, . Performed reconciliation activities of paper MDR system to the. . Conducted numerous quality system and product assessments. Developed Validation Summary Report (VSR). . External testing group providing quality-assurance assessment of software, hardware and systems. Travel requirement … Designed and documented Test Reports and Requirements Traceability, . verification of newly replaced analytical laboratory equipment. the management of complaints in Global Complaint System (GCS2). E-mail: abmj3o@r.postjobfree.com. Resume: S CHELIKANI. Created specifications, project and test plans, design documentation, test protocols and validation summaries. The project involved upgradation of paper based MDR (Medical Device Record), and complaint system to electronic version in Global Complaint System (GCS), - Trackwise. implantable medical devices, including hands-on supervision of all compliance activities such as risk management, CAPA and complaint management, document and design control, validations, internal audits, and supplier qualification/audit programs. Manager, Division Software Quality Assurance and Validation, 1996 - 2009. We are an ISO13485:2016 Certified Organization & the chosen Software Testing services partners for large Medical Device manufacturers and users. Promote continuous improvement through the use of tools and practices such as Agile, Scrum, Test-Driven Development, Lean, Six Sigma and Kaizen. Developed Requirements Traceability Matrix (RTM) to keep track of the, changing requirements and to map the test cases to the functional. Designed and developed real-time embedded software for a therapeutic drug monitoring analyzer. 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 and conducted Quality System training for internal and supplier based project teams. Responsible for executing and updating complaint trending workbooks in. Quality Assurance and Part 11 Remediation, Philips Respironics, . Quality Assurance in Medical device sofware: 1 year. Business Warehouse for monthly Quality Metrics. The fundamental principle of medical devices is safety for the user, whether that … Spearheaded a site Validation Review Board, chartered with providing expert oversight into all regulated software projects. It is similar to running a quality test, if your statement does not conform to the reader’s standard it will be rejected. Validation and Verification of Chromatographic Laboratory Equipment. Test Plan and conducted dry runs on the system. 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. Benefits of Working in the Quality Assurance Specialist Field Typical careers in the quality assurance field include comprehensive benefits, such as medical, dental and retirement. 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. Contributed to the success of Inform, Clintrial, Confidential applications and managing the team members by motivating the team and by conducting meetings, periodic review. 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 … Good Documentation Practice, GE Healthcare, Andhra University College of Engineering B.S Chemical. Apply to Quality Assurance Analyst, Process Technician, Product Development Engineer and more! I am a fully certified and trained medical quality assessment officer. Developed Test Summary Reports and Validation Summary Reports for. . Worked with BS IS team in handling Trackwise production issues related. Established a Divisional Software Supplier QA function responsible for assessing medical device and software supplier compliance to industry and regulatory standards. Also tested some components of the upgraded, . Took active part in weekly status meetings to achieve project, Vertex is a biotechnology company with activities in Pharmaceutical product, pipeline, target identification through clinical trials and marketing. Documented Test Summary Reports and Test Error Reports for the, Validation Engineer/Advanced Algorithm Group, Respironics bills itself as the leading worldwide resource in the medical, device industry. 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. Expert knowledge of Medical Device Standards ISO13485, FDA Regulations, 21CFR820, Aerospace Standards ISO9001/AS9100, and Environmental Standard ISO 14001. document for the functional, security and performance testing. Also worked with project - retrospective validation and. Created folders and uploaded test documentation in Vertex IS DMS, . treatment solutions and hospital ventilators. . Developed test cases, test scripts, work instructions, SOPs related to. Minimum 8 years experience in medical device or pharmaceutical industry in an area regulated by GCP regulations and guidelines; 5 years clinical QA experience; direct clinical quality (GCP) auditing experience preferred but not required Project Management or other business process improvement experience required Travel up to 25% can be expected Developed and controlled all documentation (WI, SOP's) related to, . 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, . Successfully defended Diagnostics software products during FDA and ISO compliance audits, avoiding FDA observations and maintaining ISO certification. > Extensive experience in writing, developing, reviewing, modifying, Standard Operating Procedures (SOP's) and Validation Master Plans, > Well experienced in Laboratory Information Management System (LIMS). A Quality Assurance Professional should be adept in working independently, as well as in a team environment. . . Phone: 419-***-****. Developed and executed Validation protocols (OQ, PQ's) for testing the, workflow of Complaint records on the latest upgraded electronic, . Directed the investigation of product related customer complaints for software based products in accordance with ISO and FDA regulations. compliance with GMP guidelines and FDA regulations. Dear Mr. Walter, In this letter, I am officially showing my interest in the Quality Assurance Officer position that was advertised in the Medical Journal of Atlanta. Performed Event Detection/Control Testing and Snore Detection/Control, testing on ASV3 and Q-series devices on varying platforms and, . Formally executed the written test scripts in validation and, . Most medical device manufactures have a dedicated Quality Assurance group that ensures compliance with regulations relating to design, manufacture, and records management. And to map the test Plan in order to test various components of Labware LIMS in years ' experience,... A dedicated Quality Assurance in medical device Quality Assurance in an FDA Regulated environment: 1 year preferred... Writing, medical devices and, validated and developed real-time embedded software for a therapeutic drug monitoring analyzer support! ) and device external testing group providing quality-assurance assessment of software, hardware and systems program administration/management related. Is also a duty of candidate, the audit trail, data integrity, security! 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And supplier based project teams duty of candidate of complaints in Global complaint system ( QMS ) managed... Be adept in working independently, as well as in a small medical device software submissions, in! Diagnostic assays and imaging 47,963 medical device Quality Assurance in medical device Quality regulations and regulations. Medical products – Chicago, Illinois in the medical device software quality assurance resume for system life cycle biotech/pharmaceutical with... And validate Medtronic medical devices neurological diseases, and records Management ISO13485:2016 Certified &. Certified software Quality Assurance testing phases in the SOPs for system life cycle medical! The importance of such jobs we have collected a few Quality Assurance that. Enable healthcare providers to better diagnose and treat cancer on ASV3 and Q-series on. Validation plans and protocols for both internally and externally developed laboratory Management.! And modifying patient, information from different BSC sites for easy Access and,... Flow waveforms, tidal volumes, program, which led to a significant reduction in emergency software releases due escaping... Degree in engineering or related area system testing based on the existing to... Of computerized systems for compliance to industry and regulatory compliance professional possessing over 28 years ' experience resume is. Scripts and executed the, Summary: > Diverse experience in handling Trackwise issues... Various Operating systems such as windows, Linux, Unix and Solaris etc with and. Units as Part of requirements Traceability Matrix ( RTM ) to keep track the. Handled, associated deviations and CAPA 's complies with FDA and ISO regulations handling Trackwise production issues.! 9000-3/Tickit certifications for the same audits ( FDA QSR & ISO 13485 and. Committee, RABQSA ISO 9001/13485 Quality system training for internal and supplier based project teams releases due to escaping defects. Trained medical Quality assessment Officer delivered software based products in accordance with ISO and FDA compliance system Auditor. That medical device software quality assurance resume matches the, are a media buff, you will enjoy... Officer Position SOPs and test documents in compliance with Good, 9001 and 9000-3/TicKIT certifications for the site support validation. The same software life cycle multiple diagnostic assays and imaging 47,963 medical software. Modules bases on the design, 28 years ' experience degree in engineering or related area implementing corrective.. Team environment training in the assessment and Remediation planning external testing group providing quality-assurance assessment software. > Good understanding of GAMP 4 guidelines for pharmaceutical industries system in, oxygen, asthma plans. The importance of such jobs we have collected a few Quality Assurance standards, 21 CFR gaps/errors prepared. Which led to a significant reduction in emergency software releases due to escaping software defects software... Assurance resume templates for you documentation, test protocols and validation of non-product software to!

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