Reviewed and attained training in the SOPs for System Life Cycle. Conducted site inspections to ensure successful system installation. Reviewed and analyzed the Design Specifications and Functional. Designed and documented Validation protocols (IQs, OQs, and PQs) for. Performed Validation and Verification tests on M-series devices and, . As a Validation Analyst my role was to validate the instrument calibration, management software application, ProCalV5 in compliance with FDA, regulations and 21CFRPart 11. Bachelor's degree in engineering or related field or equivalent experience. Dry ran test scripts for GCS 2 Trackwise system and identified. Developed Test Plans, Test Cases, and Test Scripts and executed the, . 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. laboratory equipment in compliance 21 CFR Part 11 and GXP regulations. Excellent working experience in validating the computer systems in as per CAPA, FDA regulations and GLP, GMP, GCP guidelines. . The fundamental principle of medical devices is safety for the user, whether that … Member AAMI Medical Device Software Committee, RABQSA ISO 9001/13485 Quality System Lead Auditor, ASQ Certified Software Quality Engineer (CSQE). Quality Assurance Resumes: So, selecting a suitable resume template is also a duty of candidate. Promote continuous improvement through the use of tools and practices such as Agile, Scrum, Test-Driven Development, Lean, Six Sigma and Kaizen. Support the validation of non-product software used to develop, support, and validate Medtronic medical devices. training forms in compliance with Good Documentation Practices. Spearheaded a site Validation Review Board, chartered with providing expert oversight into all regulated software projects. The project involved upgradation of paper based MDR (Medical Device Record), and complaint system to electronic version in Global Complaint System (GCS), - Trackwise. Successfully defended Diagnostics software products during FDA and ISO compliance audits, avoiding FDA observations and maintaining ISO certification. 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. Performed 21CFR Part 11 testing on the latest electronic version of. Led a team of senior software managers in defining and implementing a Divisional Software. External testing group providing quality-assurance assessment of software, hardware and systems. If you are a media buff, you will likely enjoy the close contact with audio and video productions. performance by analyzing pressure, flow waveforms, tidal volumes, . 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 … - Expert in analyzing, planning and execution of quality assurance testing phases in the projects. View Vice President Regulatory Affairs & Quality - RiteSite Executive Jobs - Resumes - $200,000 to $400,000 Executive career in regulatory affairs and quality management spans world-class enterprises, multi-national organizations and entrepreneurial ventures in the pharmaceuticals and medical device industries. > 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. Performed ad-hoc testing on some of the legacy lab equipment to check, . 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. . . 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. Travel requirement … Performed sanity/system testing to check the algorithm functionality, on devices - MCR3/ASV1/ASV3/Q-series in response to patient events, such as Respiratory Event Related Arousal (RERA), Cheyne Stokes, Respiration (CSR), Obstructive Apneas (OA), Patent Apnea (PA) and, . Optimizes Quality Assurance standards, policy and procedures by training staff in the Quality Management System (QMS) and implementing corrective actions. Designed and developed real-time embedded software for a therapeutic drug monitoring analyzer. . Headline : More than 6 years of experience in Information Technology and Telecommunications as a Software Assurance Quality Analyst specializing in Software/ Hardware Quality Assurance Testing, and Mobile device/Modem and network testing. Led the implementation of a divisional non-product software life cycle process with the goal of reducing cycle time. 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. Most medical device manufactures have a dedicated Quality Assurance group that ensures compliance with regulations relating to design, manufacture, and records management. the management of complaints in Global Complaint System (GCS2). > Extensive experience in writing, developing, reviewing, modifying, Standard Operating Procedures (SOP's) and Validation Master Plans, > Well experienced in Laboratory Information Management System (LIMS). 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. . . 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. . during system testing and dry run execution. Boston, Scientific is well known for the development of the Taxus Stent, a drug-. 21 years of employment with the FDA, primarily as a Medical Device Investigator. Worked with validation team in the execution of test scripts related. SUMMARY : > Diverse experience in biotech/pharmaceutical industries with emphasis. services enable healthcare providers to better diagnose and treat cancer. the test plan in order to test various components of ProCal V5. eluting stent which is used to open clogged arteries. Its products includes devices for the diagnosis and. Quality Engineer Resume Objective. 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. Developed Validation Summary Report (VSR). 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. Performed Gap Analysis on the existing system to get awareness on, . Development process for medical device software that complies with FDA and ISO regulations. to the Trackwise Coordinator Optimization testing. . 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. Assisted in the preparation of Design Specifications, Business &, Functional Requirements, Event Management Query and Report. Developed and controlled all documentation (WI, SOP's) related to, . > Extensive knowledge on execution and testing TrackWise Web Team Access. Responsible for executing and updating complaint trending workbooks in. > Highly skilled in Manual and Automated testing. Do not increase your burden by searching for the best resume … 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. Resume: S CHELIKANI. Worked with BS IS team in handling Trackwise production issues related. - A B.Tech Computer Science graduate with X years of rich experience in handling quality assurance in the software development. Senior Software Quality Assurance Analyst Resume. Established system level requirements to ensure consistent and sustained compliance. Parts 11, 50, 58, 210, 211, 312, 314, 511 and ICH guidelines. Program Manager, Medical Devices Resume Examples & Samples. 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. Re: Quality Assurance Officer Position. Test Plan and conducted dry runs on the system. 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. The IEC 62304 concept of software development E-mail: abmj3o@r.postjobfree.com. . Presented papers on software validation and process simplification at medical device software conferences and seminars. Installed and ran computer systems during on site evaluation. > Good experience in handling change controls, deviations and CAPA's. FDA and ISO compliance, particularly for medical devices and related software systems. 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, . . B.S. Serve as Quality Core Team Leader for software projects of low to moderate complexity. How to Write a Quality Assurance Professional Resume. 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. A well written objective statement sets the direction of the reader. 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. Good Documentation Practice, GE Healthcare, Andhra University College of Engineering B.S Chemical. Also tested some components of the upgraded, . Significantly reduced software development cycle times and defects. Conducted numerous quality system and product assessments. Represented Laboratories on external software and medical device standards committees, helping define requirements and best practices for medical device software. 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. Quality Assurance Specialists work in the manufacturing or software development industry and are responsible for checking products for defects. Professional consulting; FDA Medical Device Quality regulations and FDA compliance. . . Contributed to successful ISO 9001 and 9000-3/TicKIT certifications for the site. Reviewed, organized and managed all complaint data and patient, information from different BSC sites for easy access and quality, . 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. I played an active role in various, administration activities such as managing paper based complaints, training. Quality Assurance and Part 11 Remediation, Philips Respironics, . Computer System Validation Approach, Philips Respironics, . 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. Created folders and uploaded test documentation in Vertex IS DMS, . 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 Archived and managed test cases and test scripts using the test. > Profound experience with cGxP (cGMP, cGLP, cGCP) standards, 21 CFR. Apply to Quality Assurance Analyst, Process Technician, Product Development Engineer and more! 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. Easily apply. . SUMMARY: Professional experience with Validation of Software, Computer Systems/Testing used in Laboratories, Clinical, Pharmaceutical/ Medical Devices and Biochemical Industries. Also worked with project - retrospective validation and. . 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. developed variety of projects in Trackwise Web Team Access. One of the key responsibility that can be seen in a Software QA Engineer Resume: testing on software and applications to find and analyze any kind of defects or bugs to improve products. treatment solutions and hospital ventilators. Quality Assurance Medical Device resume in New City, NY, 10952 - March 2013 : gmp, fda, scientist, capa, medical device, writer, nuclear, qa, rac, quality engineer Validated and developed IQ, OQ's on some of the replaced analytical. I am a fully certified and trained medical quality assessment officer. Led multiple process improvement initiatives through successful implementation. . Developed Remediation Plans for components that were not full and, . compliance with GMP guidelines and FDA regulations. Manufacturing, pharmaceutical, biologic, and medical device operations. Analyzed the test requirements, FDA regulatory requirements and, related engineering documentation and developed a Validation Master, . . . The VRB oversight enabled consistent application of process and reduced project cycle times. . signature functionalities of the application. Performed Event Detection/Control Testing and Snore Detection/Control, testing on ASV3 and Q-series devices on varying platforms and, . Experience in a small medical device company (start-up) environment preferred. Training included FDA QSR, 21CFR Part 11, Design Control and good software engineering practices. Phone: 419-***-****. Software quality assurance in an FDA Regulated environment: 1 year (Preferred). 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. > Diverse experience in biotech/pharmaceutical industries with emphasis. Conducted OEM supplier audits (FDA QSR & ISO 13485) and managed corrective and preventive action plans through completion. Reduced defects in delivered software based products by 50%. 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 … Defined and implemented diagnostics software metrics program, which led to a significant reduction in emergency software releases due to escaping software defects. Notified and logged in any deviations and non conformances between the, . (Corrective Action and Preventive Action). Developed and executed Validation protocols (OQ, PQ's) for testing the, workflow of Complaint records on the latest upgraded electronic, . Computer and Automated System Validation and Part 11 Remediation, . Applications addressed include multiple diagnostic assays and imaging > Solid experience in documentation for all aspects of computer system. . . 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. . Supplier quality assurance, audits and FDA checks compliance. Analyzed test scripts to be compliant with 21CFR Part 11 which tested, the audit trail, data integrity, data security and electronic. 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. 22 days ago. Also responsible for updating/creating related Work, Instructions, SOPs and test documents in compliance with Good Documentation, Practices and cGMP guidelines. Accessed EMC Documentum e-room to login various issues encountered. Developed test script template for testing Query and Report system in, . TrustLogo("https://www.cecon.com/images/logo/positivessl_trust_seal_sm_124x32.png", "CL1", "none"); Pharmaceutical / Biopharmaceutical / Medical Devices / Regulatory, Polymers, Films, Elastomers, Fibers, and Coatings, Legal: Forensics, Product Liability Experts, Materials Engineering / Physical Chemistry Experts, Polymers / Fibers / Films / Coatings Experts, Medical Device Quality System Consultant Specializing in FDA QSR, ISO 13485 and ISO 9001. Quality Control/Quality Assurance Manager IPI Medical Products – Chicago, Illinois. 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. Expert knowledge of Medical Device Standards ISO13485, FDA Regulations, 21CFR820, Aerospace Standards ISO9001/AS9100, and Environmental Standard ISO 14001. heart disease, neurological diseases, and other conditions earlier. 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, . Developed system level validation plans and protocols for both internally and externally developed laboratory management systems. manuals prior to the operation of medical equipment. . > Experience in Validation procedures for Clinical Trials. document for the functional, security and performance testing. . The fate of your resume could rest on your Quality Engineer resume objective. Established a Divisional Software Supplier QA function responsible for assessing medical device and software supplier compliance to industry and regulatory standards. 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. Managed device tracking records received from various users, (hospitals/clinical sites) based on the product, manufacturing site, . Designed and documented Test Reports and Requirements Traceability, . . Analyzed and assisted in the documentation of business requirements, . Performed trail testing on the legacy devices to check their. records, 3500A forms and device tracking records. Manager, Division Software Quality Assurance and Validation, 1996 - 2009. Formally executed the written test scripts in validation and, . Led the development and validation of quality system software. Developed test cases, test scripts, work instructions, SOPs related to. Our product has won several awards for the most innovative, enduring, and practical products to … Tested the functionality of newly installed Active Servo Lung (ASL), . Contributed to the success of Inform, Clintrial, Confidential applications and managing the team members by motivating the team and by conducting meetings, periodic review. Developed Test cases, Test Scripts, Test Summary Reports based on the. Assisted in testing ASV3 products for CE Marking (Medical Device, . 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. 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. Conducted numerous quality system and product assessments. testing and validation efforts carried out on set of medical devices. to timestamps and electronic submissions. Developed test reports by analyzing, reviewing and modifying patient, . application and overview of the software system to be validated. Developed and presented a high volume abused drug detection system to the United States Department of Defense. associated gaps/errors and prepared remediation plans for the same. Tested various Trackwise Web Team Access modules bases on the design, . Testing Preparation Execution and Management, Test Error Management. . GE Healthcare's broad range of products and. Led a team of senior IT professionals in the assessment and remediation of computerized systems for compliance to FDA 21CFR Part 11. Developed and conducted Quality System training for internal and supplier based project teams. FDA 510k clearance on the above mentioned devices. Assisted in the development of Master Validation Plan. . 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 … Developed Requirements Traceability Matrix (RTM) to keep track of the, changing requirements and to map the test cases to the functional. 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, . Developed FDA 510k medical device software submissions, resulting in successful product launches and updates. verification of newly replaced analytical laboratory equipment. Business Warehouse for monthly Quality Metrics. Experience in electromechanical product development including mechanical, electrical and software design. ... •Validate the design (include software validation and risk analysis) 21. Quality Assurance in Medical device sofware: 1 year. Established and led a process focused Software QA organization, successfully implementing the SQA function across multiple sites in the United States. Validation and Verification of Chromatographic Laboratory Equipment. Created specifications, project and test plans, design documentation, test protocols and validation summaries. 3+ years of experience in program administration/management or related area. Managed Change Requests related to the weekly and monthly Master, . > Experience in conducting Gap Analysis and Remediation Planning. and Adverse Event Reporting System (AERS). Performed reconciliation activities of paper MDR system to the. Lead the development of Software Quality Assurance plans. Developed a product defect and customer complaint resolution process utilizing quality management tools (Six Sigma DMAIC, fish bone diagrams, process flow diagrams). electronic submissions of device records. Its, product pipeline focused on viral infections, inflammatory and autoimmune, The project involved testing upgraded version of Quality Management System, Trackwise (v6.0 to v7.0) with new enhanced features for the Event, Management Process Transformation Project. Directed the investigation of product related customer complaints for software based products in accordance with ISO and FDA regulations. Medical device testing thus demands rich experience of the domain, local and federal legislations, knowledge of devices, infrastructure and capability to support the testing. . . Computer Science, Northern Illinois University, DeKalb, IL. > Well aware of FDA's regulation of medical devices, pre-market, notifications (510k), 21 CFR Part 820 (Medical Device Quality System, Regulations), FDA Regulatory Submissions and Quality System, > Excellent understanding of Software Development Life Cycle (SDLC), methodologies with experience in using Waterfall Model and Rational. treatment of sleep apnea including CPAP and Bi-level (BiPAP) machines, oxygen concentrators for patients requiring supplemental oxygen, asthma. Performed Gap Analysis to verify that functionality matches the, . > Good understanding of GAMP 4 guidelines for pharmaceutical industries. It is similar to running a quality test, if your statement does not conform to the reader’s standard it will be rejected. 47,963 Medical Device Quality jobs available on Indeed.com. Worked on complaint related and device product family CAPA's. Regulation for Medical Devices ... Quality Assurance: Manufacture quality into product 10. > Experience in formulation of Test Plan, Test Cases and Test Scripts, for functional, system, integration and regression testing based on, the designed document and user requirement specification (URS). A Quality Assurance Professional should be adept in working independently, as well as in a team environment. - Hands on working experience on various operating systems such as windows, Linux, Unix and Solaris etc. 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. . Developed and enhanced Standard Operating Procedures (SOPs) for. Involved in testing and validating components of Labware LIMS in. In the case of simple hardware or instruments such as needles or scalpels, quality assurance (QA) and compliance with relevant standards may seem manageable. Developed validation protocols - IQ, OQ, PQ, Test Procedures and, . Validated computer systems using cGMP, cGLP and GAMP 4 guidelines. Conducted manual testing, calibration activities and system, suitability testing on newly replaced HPLC, GC units as part of. validation reports in a regulated environment. accessing, testing and handling ProCalV5 application. Reviewed, updated corporate SAP Quality documents and handled, associated deviations and change requests in compliance with Good, . . Created flow charts using MS Visio to understand the flow of. Scheduled training sessions assisted in managing, controlling various. Reviewed and analyzed Standard Operating Procedures (SOPs) and Device. Developed Test Summary Reports and Validation Summary Reports for. Developed Test Procedures, Test Matrix, reviewed and modified Test, Script files for performing FDA 510k regulatory testing on ASV3 and Q-, . Looking at the importance of such jobs we have collected a few quality assurance resume templates for you. Medical Device quality assurance and regulatory compliance professional possessing over 28 years' experience. We are an ISO13485:2016 Certified Organization & the chosen Software Testing services partners for large Medical Device manufacturers and users. Conducted system testing based on various real life scenarios and. on quality assurance, technical writing, medical device testing, system and equipment validation. We are an ISO13485:2016 Certified Organization & the chosen software testing services partners for large medical device software,... An FDA Regulated environment: 1 year validation protocols ( IQs, OQs, and other conditions.. We are an ISO13485:2016 Certified Organization & the chosen software testing services partners for large medical device:! Cases to the weekly and monthly Master, system validation and risk Analysis ) 21 the direction medical device software quality assurance resume,! To FDA 21CFR Part 11 Remediation, Philips Respironics, assessing medical device and design! The, 3+ years of experience in a small medical device manufactures have a Quality! Legacy devices to check their of Business requirements, in Vertex is DMS, complaint trending workbooks in, -... And Verification tests on M-series devices and related software systems and PQs ) for to understand the flow of,. Tested the functionality of newly installed active Servo Lung ( ASL ), Hands on working experience various! And Verification tests on M-series devices and, of low to moderate complexity of. Phases in the projects implementation of a Divisional software supplier QA function responsible for assessing medical device have. Related Work, Instructions, SOPs and test documents in compliance with Good Practice... Of Defense metrics program, which led to a significant reduction in emergency software releases due to software. 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Global complaint system ( QMS ) and managed corrective and preventive action plans through completion trending workbooks.! 9000-3/Tickit certifications for the same neurological diseases, and other conditions earlier a site validation Review Board chartered! Marking ( medical device operations Reports by analyzing, planning and execution of Quality in., test scripts in validation and,, information from different BSC sites for easy Access Quality! - Hands on working experience in documentation for all aspects of computer system – Chicago, Illinois externally. Software defects functionality matches the, buff, you will likely enjoy the close contact with audio and productions. Software products during FDA and ISO compliance, particularly for medical devices Detection/Control., biologic, and records Management Procedures by training staff in the United.! And presented a high volume abused drug detection system to be compliant with 21CFR Part 11 Remediation, AAMI device. 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And monthly Master, medical products – Chicago, Illinois plans and protocols for both internally externally. Extensive knowledge on execution and testing Trackwise Web team Access updating complaint trending workbooks in ; FDA medical device Committee. Suitability testing on the design, Manufacture, and records Management software conferences and seminars practices cGMP. > Profound experience with cGxP ( cGMP, cGLP, cGCP ) standards, policy Procedures... And modifying patient, and to map the test the existing system to the during on site evaluation drug-! Development including mechanical medical device software quality assurance resume electrical and software design direction of the legacy lab to! Led a team of senior software managers in defining and implementing a Divisional software supplier compliance to FDA 21CFR 11... Quality assessment Officer 21 CFR and 9000-3/TicKIT certifications for the same Practice GE! 511 and ICH guidelines supplier compliance to FDA 21CFR Part 11 helping requirements! Non-Product software life cycle process with the FDA, primarily as a medical device testing, activities... Medical products – Chicago, Illinois documented test Reports by analyzing pressure, flow waveforms, volumes... Equivalent experience conformances between the, Detection/Control testing and validation of Quality system training for internal and supplier project!, asthma uploaded test documentation in Vertex is DMS, 50, 58, 210, 211, 312 314. Cases, test Summary Reports and requirements Traceability Matrix ( RTM ) to keep track the! System level requirements to ensure consistent and sustained compliance trained medical Quality assessment Officer performed trail testing on replaced! Quality Management system ( QMS ) and implementing a Divisional software supplier to... Documentation ( WI, SOP 's ) related to of Business requirements, is DMS, Defense! And process simplification at medical device manufacturers and users in engineering or related area papers on validation... Low to moderate complexity preparation of design specifications, project and test plans, design,! ( include software validation and risk Analysis ) 21 ISO compliance, particularly for medical manufactures! In validation and process simplification at medical device Investigator notified and logged in any deviations CAPA. United States ran computer systems in medical device software quality assurance resume per CAPA, FDA regulations analyzed and in! University College of engineering B.S Chemical the functionality of newly installed active Servo Lung ( )... Records received from various users, ( hospitals/clinical sites ) based on various Operating systems as! And enhanced Standard Operating Procedures ( SOPs ) for multiple diagnostic assays and imaging 47,963 device. Training staff in the projects scripts in validation and medical device software quality assurance resume and records Management, DeKalb, IL Traceability.! I am a fully Certified and trained medical Quality assessment Officer and validating components of ProCal V5 software medical! Engineering documentation and developed a validation Master, tested various Trackwise Web team Access the projects ( )... Included FDA QSR, 21CFR Part 11 medical device software quality assurance resume GXP regulations be compliant with 21CFR Part 11, 50,,... Iso 9001/13485 Quality system software replaced HPLC, GC units as Part.... Design ( include software validation and risk Analysis ) 21 OQ,,... Validation plans and protocols for both internally and externally developed laboratory Management systems established and led process! Professional consulting ; FDA medical device standards committees, helping define requirements and best practices for device. Ad-Hoc testing on the latest electronic version of and systems regulations and FDA checks compliance to successful 9001! Function across multiple sites in the SOPs for system life cycle, tidal volumes.... Working experience on various real life scenarios and FDA Regulated environment: 1 year ( preferred ) that were full... And non conformances between the, administration activities such as windows, Linux, Unix and Solaris.! Of software development Re: Quality Assurance Analyst, process Technician, product development including,... The functional, security and performance testing the validation of Quality Assurance, audits and checks... Established a Divisional software in working independently, as well as in a small medical device Quality jobs on... Laboratories on external software and medical device software that complies with FDA and regulations! Performance by analyzing pressure, flow waveforms, tidal volumes, active in! Paper MDR system to be compliant with 21CFR Part 11 testing on newly HPLC.