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. Established system level requirements to ensure consistent and sustained compliance. 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. 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. . Looking at the importance of such jobs we have collected a few quality assurance resume templates for you. 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. performance by analyzing pressure, flow waveforms, tidal volumes, . . Worked on complaint related and device product family CAPA's. > Extensive experience in writing, developing, reviewing, modifying, Standard Operating Procedures (SOP's) and Validation Master Plans, > Well experienced in Laboratory Information Management System (LIMS). . Reviewed and analyzed the Design Specifications and Functional. The fate of your resume could rest on your Quality Engineer resume objective. 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. 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. Quality Assurance Specialists work in the manufacturing or software development industry and are responsible for checking products for defects. 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. Quality Assurance in Medical device sofware: 1 year. Performed Gap Analysis on the existing system to get awareness on, . developed variety of projects in Trackwise Web Team Access. 47,963 Medical Device Quality jobs available on Indeed.com. 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. Lead the development of Software Quality Assurance plans. Conducted OEM supplier audits (FDA QSR & ISO 13485) and managed corrective and preventive action plans through completion. electronic submissions of device records. Established and led a process focused Software QA organization, successfully implementing the SQA function across multiple sites in the United States. . Notified and logged in any deviations and non conformances between the, . to the Trackwise Coordinator Optimization testing. Scheduled training sessions assisted in managing, controlling various. the test plan in order to test various components of ProCal V5. 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. Developed a product defect and customer complaint resolution process utilizing quality management tools (Six Sigma DMAIC, fish bone diagrams, process flow diagrams). Promote continuous improvement through the use of tools and practices such as Agile, Scrum, Test-Driven Development, Lean, Six Sigma and Kaizen. . Established a Divisional Software Supplier QA function responsible for assessing medical device and software supplier compliance to industry and regulatory standards. Performed Gap Analysis to verify that functionality matches the, . Conducted numerous quality system and product assessments. 21 years of employment with the FDA, primarily as a Medical Device Investigator. during system testing and dry run execution. . 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. > Extensive knowledge on execution and testing TrackWise Web Team Access. Serve as Quality Core Team Leader for software projects of low to moderate complexity. Conducted system testing based on various real life scenarios and. . > Experience in conducting Gap Analysis and Remediation Planning. verification of newly replaced analytical laboratory equipment. FDA and ISO compliance, particularly for medical devices and related software systems. Analyzed test scripts to be compliant with 21CFR Part 11 which tested, the audit trail, data integrity, data security and electronic. Conducted numerous quality system and product assessments. training forms in compliance with Good Documentation Practices. Analyzed and assisted in the documentation of business requirements, . Analyzed the test requirements, FDA regulatory requirements and, related engineering documentation and developed a Validation Master, . Computer System Validation Approach, Philips Respironics, . The project involved upgradation of paper based MDR (Medical Device Record), and complaint system to electronic version in Global Complaint System (GCS), - Trackwise. Led a team of senior IT professionals in the assessment and remediation of computerized systems for compliance to FDA 21CFR Part 11. Regulation for Medical Devices ... Quality Assurance: Manufacture quality into product 10. . Support the validation of non-product software used to develop, support, and validate Medtronic medical devices. 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 … I played an active role in various, administration activities such as managing paper based complaints, training. Validation and Verification of Chromatographic Laboratory Equipment. - Hands on working experience on various operating systems such as windows, Linux, Unix and Solaris etc. SUMMARY: Professional experience with Validation of Software, Computer Systems/Testing used in Laboratories, Clinical, Pharmaceutical/ Medical Devices and Biochemical Industries. Developed system level validation plans and protocols for both internally and externally developed laboratory management systems. . Performed ad-hoc testing on some of the legacy lab equipment to check, . Defined and implemented diagnostics software metrics program, which led to a significant reduction in emergency software releases due to escaping software defects. - A B.Tech Computer Science graduate with X years of rich experience in handling quality assurance in the software development. 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. . Performed Event Detection/Control Testing and Snore Detection/Control, testing on ASV3 and Q-series devices on varying platforms and, . Travel requirement … . Significantly reduced software development cycle times and defects. the management of complaints in Global Complaint System (GCS2). Most medical device manufactures have a dedicated Quality Assurance group that ensures compliance with regulations relating to design, manufacture, and records management. 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. Quality Engineer Resume Objective. Performed Validation and Verification tests on M-series devices and, . . Test Plan and conducted dry runs on the system. Validated computer systems using cGMP, cGLP and GAMP 4 guidelines. . 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. and Adverse Event Reporting System (AERS). records, 3500A forms and device tracking records. Managed device tracking records received from various users, (hospitals/clinical sites) based on the product, manufacturing site, . 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. Worked with validation team in the execution of test scripts related. . Developed validation protocols - IQ, OQ, PQ, Test Procedures and, . Directed the investigation of product related customer complaints for software based products in accordance with ISO and FDA regulations. Its products includes devices for the diagnosis and. > Good experience in handling change controls, deviations and CAPA's. . 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 … 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. document for the functional, security and performance testing. . > 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). . Spearheaded a site Validation Review Board, chartered with providing expert oversight into all regulated software projects. Reduced defects in delivered software based products by 50%. > Highly skilled in Manual and Automated testing. 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. - Expert in analyzing, planning and execution of quality assurance testing phases in the projects. Optimizes Quality Assurance standards, policy and procedures by training staff in the Quality Management System (QMS) and implementing corrective actions. Developed Requirements Traceability Matrix (RTM) to keep track of the, changing requirements and to map the test cases to the functional. Assisted in the development of Master Validation Plan. 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. 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. Training included FDA QSR, 21CFR Part 11, Design Control and good software engineering practices. Quality Assurance and Part 11 Remediation, Philips Respironics, . Performed 21CFR Part 11 testing on the latest electronic version of. Program Manager, Medical Devices Resume Examples & Samples. treatment solutions and hospital ventilators. Installed and ran computer systems during on site evaluation. 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. Resume: S CHELIKANI. Professional consulting; FDA Medical Device Quality regulations and FDA compliance. manuals prior to the operation of medical equipment. 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. 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. Designed and developed real-time embedded software for a therapeutic drug monitoring analyzer. > 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. Senior Software Quality Assurance Analyst Resume. Developed Test cases, Test Scripts, Test Summary Reports based on the. validation reports in a regulated environment. I am a fully certified and trained medical quality assessment officer. The fundamental principle of medical devices is safety for the user, whether that … Contributed to the success of Inform, Clintrial, Confidential applications and managing the team members by motivating the team and by conducting meetings, periodic review. 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. 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, . testing and validation efforts carried out on set of medical devices. Developed and enhanced Standard Operating Procedures (SOPs) for. It is similar to running a quality test, if your statement does not conform to the reader’s standard it will be rejected. . Involved in testing and validating components of Labware LIMS in. Do not increase your burden by searching for the best resume … . Developed test script template for testing Query and Report system in, . > 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. signature functionalities of the application. Computer Science, Northern Illinois University, DeKalb, IL. 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. 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. Worked with BS IS team in handling Trackwise production issues related. > Diverse experience in biotech/pharmaceutical industries with emphasis. Led multiple process improvement initiatives through successful implementation. Re: Quality Assurance Officer Position. 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. We are an ISO13485:2016 Certified Organization & the chosen Software Testing services partners for large Medical Device manufacturers and users. Medical Device quality assurance and regulatory compliance professional possessing over 28 years' experience. Also worked with project - retrospective validation and. 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. Reviewed, updated corporate SAP Quality documents and handled, associated deviations and change requests in compliance with Good, . Developed and conducted Quality System training for internal and supplier based project teams. laboratory equipment in compliance 21 CFR Part 11 and GXP regulations. 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. eluting stent which is used to open clogged arteries. . How to Write a Quality Assurance Professional Resume. Performed trail testing on the legacy devices to check their. > Solid experience in documentation for all aspects of computer system. Developed Remediation Plans for components that were not full and, . compliance with GMP guidelines and FDA regulations. Dry ran test scripts for GCS 2 Trackwise system and identified. Developed FDA 510k medical device software submissions, resulting in successful product launches and updates. on quality assurance, technical writing, medical device testing, system and equipment validation. Developed Test Plans, Test Cases, and Test Scripts and executed the, . Also tested some components of the upgraded, . Testing Preparation Execution and Management, Test Error Management. 3+ years of experience in program administration/management or related area. Led the development and validation of quality system software. If you are a media buff, you will likely enjoy the close contact with audio and video productions. Bachelor's degree in engineering or related field or equivalent experience. . Developed Validation Summary Report (VSR). 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. 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, . services enable healthcare providers to better diagnose and treat cancer. The VRB oversight enabled consistent application of process and reduced project cycle times. > Experience in Validation procedures for Clinical Trials. Quality Assurance Medical Device resume in New City, NY, 10952 - March 2013 : gmp, fda, scientist, capa, medical device, writer, nuclear, qa, rac, quality engineer Developed Test Procedures, Test Matrix, reviewed and modified Test, Script files for performing FDA 510k regulatory testing on ASV3 and Q-, . Conducted manual testing, calibration activities and system, suitability testing on newly replaced HPLC, GC units as part of. Applications addressed include multiple diagnostic assays and imaging . . Created folders and uploaded test documentation in Vertex IS DMS, . to timestamps and electronic submissions. Accessed EMC Documentum e-room to login various issues encountered. Parts 11, 50, 58, 210, 211, 312, 314, 511 and ICH guidelines. Manager, Division Software Quality Assurance and Validation, 1996 - 2009. In the case of simple hardware or instruments such as needles or scalpels, quality assurance (QA) and compliance with relevant standards may seem manageable. Tested the functionality of newly installed Active Servo Lung (ASL), . Performed reconciliation activities of paper MDR system to the. ... •Validate the design (include software validation and risk analysis) 21. Formally executed the written test scripts in validation and, . . Good Documentation Practice, GE Healthcare, Andhra University College of Engineering B.S Chemical. . Quality Assurance Resumes: So, selecting a suitable resume template is also a duty of candidate. Business Warehouse for monthly Quality Metrics. A Quality Assurance Professional should be adept in working independently, as well as in a team environment. , PQ, test cases, test Procedures and, software that complies with FDA and ISO compliance particularly. 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