. Parts 11, 50, 58, 210, 211, 312, 314, 511 and ICH guidelines. eluting stent which is used to open clogged arteries. 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. Worked with validation team in the execution of test scripts related. . SUMMARY : > Diverse experience in biotech/pharmaceutical industries with emphasis. the management of complaints in Global Complaint System (GCS2). Resume: S CHELIKANI. 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. > 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. Quality Assurance Resumes: So, selecting a suitable resume template is also a duty of candidate. Training included FDA QSR, 21CFR Part 11, Design Control and good software engineering practices. Installed and ran computer systems during on site evaluation. 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. FDA 510k clearance on the above mentioned devices. to timestamps and electronic submissions. 47,963 Medical Device Quality jobs available on Indeed.com. during system testing and dry run execution. Contributed to the success of Inform, Clintrial, Confidential applications and managing the team members by motivating the team and by conducting meetings, periodic review. 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. Reviewed, updated corporate SAP Quality documents and handled, associated deviations and change requests in compliance with Good, . 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. performance by analyzing pressure, flow waveforms, tidal volumes, . Tested the functionality of newly installed Active Servo Lung (ASL), . 22 days ago. Senior Software Quality Assurance Analyst Resume. . 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, . Testing Preparation Execution and Management, Test Error Management. Quality Assurance Medical Device resume in New City, NY, 10952 - March 2013 : gmp, fda, scientist, capa, medical device, writer, nuclear, qa, rac, quality engineer 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 Analyzed and assisted in the documentation of business requirements, . We are an ISO13485:2016 Certified Organization & the chosen Software Testing services partners for large Medical Device manufacturers and users. - A B.Tech Computer Science graduate with X years of rich experience in handling quality assurance in the software development. 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, . The IEC 62304 concept of software development > Diverse experience in biotech/pharmaceutical industries with emphasis. Formally executed the written test scripts in validation and, . Led the development and validation of quality system software. Led multiple process improvement initiatives through successful implementation. SUMMARY: Professional experience with Validation of Software, Computer Systems/Testing used in Laboratories, Clinical, Pharmaceutical/ Medical Devices and Biochemical Industries. Developed validation protocols - IQ, OQ, PQ, Test Procedures and, . Created folders and uploaded test documentation in Vertex IS DMS, . Performed reconciliation activities of paper MDR system to the. Conducted numerous quality system and product assessments. . Optimizes Quality Assurance standards, policy and procedures by training staff in the Quality Management System (QMS) and implementing corrective actions. Re: Quality Assurance Officer Position. Medical Device quality assurance and regulatory compliance professional possessing over 28 years' experience. Successfully defended Diagnostics software products during FDA and ISO compliance audits, avoiding FDA observations and maintaining ISO certification. . testing and validation efforts carried out on set of medical devices. > Highly skilled in Manual and Automated testing. treatment solutions and hospital ventilators. 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. Developed system level validation plans and protocols for both internally and externally developed laboratory management systems. 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. Managed Change Requests related to the weekly and monthly Master, . - Hands on working experience on various operating systems such as windows, Linux, Unix and Solaris etc. 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 Test cases, Test Scripts, Test Summary Reports based on the. Validated and developed IQ, OQ's on some of the replaced analytical. Business Warehouse for monthly Quality Metrics. Manager, Division Software Quality Assurance and Validation, 1996 - 2009. . A well written objective statement sets the direction of the reader. Established system level requirements to ensure consistent and sustained compliance. > Extensive experience in writing, developing, reviewing, modifying, Standard Operating Procedures (SOP's) and Validation Master Plans, > Well experienced in Laboratory Information Management System (LIMS). Contributed to successful ISO 9001 and 9000-3/TicKIT certifications for the site. Experience in electromechanical product development including mechanical, electrical and software design. Assisted in the development of Master Validation Plan. treatment of sleep apnea including CPAP and Bi-level (BiPAP) machines, oxygen concentrators for patients requiring supplemental oxygen, asthma. Developed Test Summary Reports and Validation Summary Reports for. > Profound experience with cGxP (cGMP, cGLP, cGCP) standards, 21 CFR. Analyzed the test requirements, FDA regulatory requirements and, related engineering documentation and developed a Validation Master, . Conducted manual testing, calibration activities and system, suitability testing on newly replaced HPLC, GC units as part of. Validation and Verification of Chromatographic Laboratory Equipment. Developed test reports by analyzing, reviewing and modifying patient, . . . Promote continuous improvement through the use of tools and practices such as Agile, Scrum, Test-Driven Development, Lean, Six Sigma and Kaizen. Regulation for Medical Devices ... Quality Assurance: Manufacture quality into product 10. . Designed and documented Validation protocols (IQs, OQs, and PQs) for. Created specifications, project and test plans, design documentation, test protocols and validation summaries. Quality Assurance Specialists work in the manufacturing or software development industry and are responsible for checking products for defects. Developed test script template for testing Query and Report system in, . . Medical device testing thus demands rich experience of the domain, local and federal legislations, knowledge of devices, infrastructure and capability to support the testing. > Experience in Validation procedures for Clinical Trials. . Established a Divisional Software Supplier QA function responsible for assessing medical device and software supplier compliance to industry and regulatory standards. Its products includes devices for the diagnosis and. 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. 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. manuals prior to the operation of medical equipment. compliance with GMP guidelines and FDA regulations. validation reports in a regulated environment. Archived and managed test cases and test scripts using the test. 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. 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. Developed Test Procedures, Test Matrix, reviewed and modified Test, Script files for performing FDA 510k regulatory testing on ASV3 and Q-, . Apply to Quality Assurance Analyst, Process Technician, Product Development Engineer and more! Performed Gap Analysis on the existing system to get awareness on, . Computer and Automated System Validation and Part 11 Remediation, . > Experience in conducting Gap Analysis and Remediation Planning. Directed the investigation of product related customer complaints for software based products in accordance with ISO and FDA regulations. The VRB oversight enabled consistent application of process and reduced project cycle times. Conducted numerous quality system and product assessments. As a Validation Analyst my role was to validate the instrument calibration, management software application, ProCalV5 in compliance with FDA, regulations and 21CFRPart 11. Presented papers on software validation and process simplification at medical device software conferences and seminars. Worked on complaint related and device product family CAPA's. 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. signature functionalities of the application. . Assisted in testing ASV3 products for CE Marking (Medical Device, . 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, . The fundamental principle of medical devices is safety for the user, whether that … Our product has won several awards for the most innovative, enduring, and practical products to … the test plan in order to test various components of ProCal V5. . and Adverse Event Reporting System (AERS). Notified and logged in any deviations and non conformances between the, . Computer Science, Northern Illinois University, DeKalb, IL. verification of newly replaced analytical laboratory equipment. 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. Developed FDA 510k medical device software submissions, resulting in successful product launches and updates. GE Healthcare's broad range of products and. 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. Accessed EMC Documentum e-room to login various issues encountered. Reviewed and analyzed the Design Specifications and Functional. 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. . Led the implementation of a divisional non-product software life cycle process with the goal of reducing cycle time. 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. 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. ... •Validate the design (include software validation and risk analysis) 21. Performed 21CFR Part 11 testing on the latest electronic version of. > Extensive knowledge on execution and testing TrackWise Web Team Access. . 21 years of employment with the FDA, primarily as a Medical Device Investigator. 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. Quality Assurance and Part 11 Remediation, Philips Respironics, . E-mail: firstname.lastname@example.org. records, 3500A forms and device tracking records. In the case of simple hardware or instruments such as needles or scalpels, quality assurance (QA) and compliance with relevant standards may seem manageable. A Quality Assurance Professional should be adept in working independently, as well as in a team environment. Analyzed test scripts to be compliant with 21CFR Part 11 which tested, the audit trail, data integrity, data security and electronic. Represented Laboratories on external software and medical device standards committees, helping define requirements and best practices for medical device software. Performed Validation and Verification tests on M-series devices and, . Responsible for executing and updating complaint trending workbooks in. training forms in compliance with Good Documentation Practices. Manufacturing, pharmaceutical, biologic, and medical device operations. Also tested some components of the upgraded, . Scheduled training sessions assisted in managing, controlling various. Also worked with project - retrospective validation and. Performed Event Detection/Control Testing and Snore Detection/Control, testing on ASV3 and Q-series devices on varying platforms and, . . External testing group providing quality-assurance assessment of software, hardware and systems. How to Write a Quality Assurance Professional Resume. Good Documentation Practice, GE Healthcare, Andhra University College of Engineering B.S Chemical. Developed test cases, test scripts, work instructions, SOPs related to. . Developed Remediation Plans for components that were not full and, . If you are a media buff, you will likely enjoy the close contact with audio and video productions. 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. FDA and ISO compliance, particularly for medical devices and related software systems. Bachelor's degree in engineering or related field or equivalent experience. Quality Control/Quality Assurance Manager IPI Medical Products – Chicago, Illinois. Assisted in the preparation of Design Specifications, Business &, Functional Requirements, Event Management Query and Report. 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. It is similar to running a quality test, if your statement does not conform to the reader’s standard it will be rejected. Boston, Scientific is well known for the development of the Taxus Stent, a drug-. . . 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. . Also responsible for updating/creating related Work, Instructions, SOPs and test documents in compliance with Good Documentation, Practices and cGMP guidelines. 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. Conducted OEM supplier audits (FDA QSR & ISO 13485) and managed corrective and preventive action plans through completion. application and overview of the software system to be validated. 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. 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. 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. . Tested various Trackwise Web Team Access modules bases on the design, . . 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 … 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. Development process for medical device software that complies with FDA and ISO regulations. Performed ad-hoc testing on some of the legacy lab equipment to check, . B.S. Travel requirement … The project involved upgradation of paper based MDR (Medical Device Record), and complaint system to electronic version in Global Complaint System (GCS), - Trackwise. to the Trackwise Coordinator Optimization testing. Developed and enhanced Standard Operating Procedures (SOPs) for. Reviewed and analyzed Standard Operating Procedures (SOPs) and Device. 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. 3+ years of experience in program administration/management or related area. Developed a product defect and customer complaint resolution process utilizing quality management tools (Six Sigma DMAIC, fish bone diagrams, process flow diagrams). Professional consulting; FDA Medical Device Quality regulations and FDA compliance. Performed Gap Analysis to verify that functionality matches the, . . Most medical device manufactures have a dedicated Quality Assurance group that ensures compliance with regulations relating to design, manufacture, and records management. 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. > 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. I am a fully certified and trained medical quality assessment officer. Experience in a small medical device company (start-up) environment preferred. 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. . Software quality assurance in an FDA Regulated environment: 1 year (Preferred). - Expert in analyzing, planning and execution of quality assurance testing phases in the projects. > Good understanding of GAMP 4 guidelines for pharmaceutical industries. laboratory equipment in compliance 21 CFR Part 11 and GXP regulations. . Quality Assurance in Medical device sofware: 1 year. The fate of your resume could rest on your Quality Engineer resume objective. Member AAMI Medical Device Software Committee, RABQSA ISO 9001/13485 Quality System Lead Auditor, ASQ Certified Software Quality Engineer (CSQE). Expert knowledge of Medical Device Standards ISO13485, FDA Regulations, 21CFR820, Aerospace Standards ISO9001/AS9100, and Environmental Standard ISO 14001. Program Manager, Medical Devices Resume Examples & Samples. Test Plan and conducted dry runs on the system. Led a team of senior software managers in defining and implementing a Divisional Software. Computer System Validation Approach, Philips Respironics, . Support the validation of non-product software used to develop, support, and validate Medtronic medical devices. 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. . Significantly reduced software development cycle times and defects. Phone: 419-***-****. Developed Test Plans, Test Cases, and Test Scripts and executed the, . Developed and presented a high volume abused drug detection system to the United States Department of Defense. Reduced defects in delivered software based products by 50%. 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