A Quality Systems Analyst evaluates products, systems, and software and ensures that it is free of defects and meets the stipulated quality standards. Responsibilities listed on the Quality Systems Analyst Resume include – developing and executing test plans and ensuring the objectives are met, implementing and monitoring test scripts to assess reliability, functionality, performance, and quality of service; identifying and remedy defects within the production process, recommending and implementing preventive and corrective actions, compiling and analyzing statistical data, drafting quality assurance policies and procedures; investigating customer complaints and product issues, and ensuring ongoing compliance with industry-standard requirements.
Those seeking this job role normally possess the following skills – experience in quality inspection, testing, and auditing; strong computer skills, knowledge of QA databases and applications; and meticulous attention to detail. A bachelor’s degree in Computer Science or Information Systems is required to work in this capacity.
Summary : Obtained many years of quality responsibility with global organizations. Proficient in implementing and continuously improving production and manufacturing systems. Skilled in high volume and lean manufacturing. Applied kaizen principles to assist in creating and maintaining world class manufacturing processes.
Skills : Software Development, MS Sql Server, .Net.
Description :
Expanded to include the following: -Served on management team for implementation of Process Management System.
Routinely audited key manufacturing processes and provided Process Managers with feedback; and issued progress reports to management personnel.
Conducted monthly audits of key manufacturing processes and issued report to management personnel.
Facilitated the effort to automate process for certifying finished product.
Automation resulted in improved efficiency (60%), increased accuracy and ensured customer satisfaction.
Led continuous improvement events that included a core team of 8-12 participants and an additional 10 to 15 persons with varying levels of involvement.
Served as primary point of contact for all customer audits.
Experience
7-10 Years
Level
Management
Education
Associates In Computer Programming
Quality Systems Analyst Resume
Headline : A forward-thinking and performance-driven quality professional with a demonstrated track record of achievement in statistical analysis, root cause investigation, and training and development. Highly motivated to support development and manufacture of products that directly improve patients' lives. Proven expertise in regulatory requirements and quality processes.
Skills : Statistical Analysis, Corrective And Preventive Action, Auditing, Change Management, Training & Development, Regulatory Compliance.
Description :
Prepared, ran, and maintained site Management Review Meetings.
Tracked, trend, and performed statistical analysis on metrics.
Assigned and ensured closure of action items.
Performed investigations and effectiveness checks on corrective and preventive actions (CAPAs) and internal, notified body, and FDA audit findings.
Supported and maintained CATSWeb, Abbott Vascular's electronic exception database.
Provided training on CAPA investigation and documentation for Abbott sites.
Supported and maintain Plateau Learning Management System (LMS), Abbott Vascular's internal training system.
Experience
5-7 Years
Level
Executive
Education
BA
Quality Systems Analyst Resume
Summary : Skilled and highly collaborative quality professional who enjoys bringing ideas to fruition by engaging stakeholders at all levels. Extensive experience with people, aptitude with computer applications, and excellent interpersonal skills allow me to facilitate ideas into new processes, improvement activities, and to make data accessible to both management and the end-user to support the goal of continuous improvement.
Skills : MS Office, Visio, Project, InfinityQS - Admin, CATSWeb - Admin, ViewPoint, Process Monitoring.
Description :
Worked with vendors to implement a data analysis and visualization (tableau) system (Viewics) generated from the LIS (Sunquest).
Implemented and maintain a major upgrade in the Quality Management System (document control, incident reporting) (Paradigm), coordinated training over 200 users, and function as primary user support.
Developed real-time turnaround time monitors for alerting lab personnel to collected but not received and received but not resulted test orders, which trigger immediate order tracking when specified time thresholds are exceeded Created a user-friendly database to assist laboratory management in monitoring competency issues for all technical staff, as required by our accrediting organization, The Joint Commission.
Developed weekly individual error reports for order entry and phlebotomy staff to monitor their performance, allowing them to become proactive participants in continuous improvement.
Provided system support to all users of designated laboratory systems applications.
Coordinated the implementation of system upgrades.
Assisted in the resolution of problems related to these applications and in the implementation of system upgrades.
Experience
10+ Years
Level
Senior
Education
M.S. In Counseling
Quality Systems Analyst Resume
Headline : Looking for the Quality Systems Analyst position of a software developer where my creative thinking and skills in application development using modern development tools will be utilized for the betterment of the company.
Acted as Coordinator for Regulatory Submissions of class I and class II devices.
Created database for tracking documents relating to FDA GMP and ISO 9000 compliance, including Quality Manual, DMRs, and DHFs to ensure document files were in compliance.
Set up database for regulatory tracking of Customer Complaints and System Performance Reports.
Formulated company procedure and policy documents regarding QA Documentation, MIS, and Help Desk.
Created, coordinated, and operated Help Desk functions for corporate headquarters.
Organized weekly training seminars on computer use.
Experience
5-7 Years
Level
Executive
Education
BS
Quality Systems Analyst Resume
Summary : Quality Systems Analyst with over 7 years of experience in the food processing and manufacturing industry. I'm interested in pursuing a position as a Quality Supervisor within a company with growth potential.
Supported the design, implementation, maintenance, and improvement of Supply Chain Quality and Food Safety Management Systems.
Served as the Document Management Administrator for all departments.
Verified records from all departments Serve as back-up, in the absence of the QA Department Manager.
Monitored Sanitation and preventive maintenance schedule Improving procedures within the Quality Department Monitor and update all QA related programs Evaluating and categorizing complaints from customers and preparing reports and graphs monthly o Supporting the QA manager in any complaint investigations.
Participated in new product sensory evaluations.
Membered of the HACCP team Managing and resolving QA Hold issues.
Drafted SOPs Supervising QA Techs Ordering needed equipment, kits, new equipment set up.
Experience
10+ Years
Level
Senior
Education
Bachelor Of Science
Quality Systems Analyst Resume
Objective : To establish a long-term career in a company where I may utilize my Quality Systems Analyst professional skills and knowledge to be an effective Associate Program Manager and inspiration to those around me.
Analyzed defects and problem areas as quality risks by identifying system enhancements and/or new specifications including coding to resolve issues.
Assisted with introduction of changes/upgrades/implementation of existing/new products through various stages of the lifecycle from requirements through deployment within environment.
Identified and documented best practices on various proprietary tools for firm wide use.
Provided end user support and training for the business segment on various proprietary tools.
Gathered data analysis for creating and maintain technology end user support and documentation.
Worked with project teams to implement enhancements and new development by identifying proper solutions for requirements, risk, testing, and design.
Experienced with language scripts including: SQL, HTML, and XML.
Experience
2-5 Years
Level
Executive
Education
BA
Quality Systems Analyst Resume
Headline : Highly qualified Quality Systems Analyst with experience in the industry. Enjoy creative problem solving and getting exposure on multiple projects, and I would excel in the collaborative environment on which your company prides itself.
Skills : Proficient In Microsoft Office Programs, Outlook, Sharepoint, M2M.
Description :
Daily handled PPAP, ISIR, and FAI documentation for new and existing customers.
Prepared Mag Particle inspection reports, radiographic result paperwork, ultrasonic inspection paperwork and organize and submit full documentation for outside customers.
Developed control plans, part specific work instructions and several powerpoints for customer meetings.
Experienced preparing deviation requests and other relevant documentation.
Developed presentations involving resolution of customer complaint history and potential corrective actions.
Worked on a project for the improvement of certain patterns and the trying to lessen inclusions in castings resulting from molding and pouring processes.
Involved gathering and analyzing data and finding potential resolutions.
Experience
5-7 Years
Level
Executive
Education
BS In Organizational Leadership
Quality Systems Analyst Resume
Objective : To obtain a challenging, responsible, long-term position with a progressive company in order to expand my abilities and contribute technically.
Skills : Microsoft Office, Organizational Skills.
Description :
Analyzed and defined requirements from contracts, standards, and company procedures.
Evaluated processes based on requirements, develop solutions to correct deficiencies.
Reviewed responses to government-issued CARs and identify trends.
Communicated essential quality information at meetings.
Generated reports and flowcharts.
Developed and executed internal audit plan for ISO 9001:2008 compliance.
Edited Quality Manual and drafted procedures required by ISO 9001:2008.
Experience
2-5 Years
Level
Executive
Education
MS
Quality Systems Analyst Resume
Objective : Seeking a Quality Systems Analyst position with an outstanding career opportunity that will offer a rewarding work environment along with a winning team that will fully utilize management skills.
Skills : Six Sigma Green Belt, ISO9000 Auditor.
Description :
Conducted internal ISO 9000 quality audits.
Developed general safety and training manuals.
Trained personnel with various processes and procedures.
Assisted with the generation of ROI calculations for specific one-time purchases.
Created new processes and procedures.
Proactively introduce new suppliers to the vendor base Performed random quality checks in field and internally.
Coordinated, managed and executed assigned special projects.
Experience
2-5 Years
Level
Executive
Education
BS In Business Administration
Quality Systems Analyst Resume
Summary : Quality Systems Analyst with over 30 years of experience within several job disciplines. Lean Manufacturing director for 5 years with substantial product flow improvements and cost savings. Detail-oriented ISO Lead Auditor for 6 years. Proven ability to improve performance to create highly profitable programs through training and partner relationships.
Skills : Quality Assurance, Compliance.
Description :
Prioritized customer requests and determined based on business need which requests would be included in scheduled releases.
Gathered requirements using interviews, surveys, business processes and workflow analysis.
Documented software defects using a tracking system and prioritized as necessary for inclusion in upcoming project releases.
Composed test cases, scenarios, scripts, and/or procedures to be used to verify all changes were correct and accurate prior to release to the production environment.
Reviewed latest software documentation to guarantee technical accuracy, compliance, and completeness.
Developed, analyzed and managed project schedules.
Collaborated with end users to evaluate, diagnose problems, and recommended solutions.
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