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: abmj3o@r.postjobfree.com. 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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