Supported the successful implementation of a global document management system (Global Project Team Member/ Local Site Lead) Initiated and oversaw the implementation of TrackWise Quality Management tracking system in the US (Change Management, Deviations, CAPA, Complaints Handling) Successful upgrading of the Training program ensuring cGMP compliance (Observed as an industry best practice). Quality assurance focuses on improving the software development process and making it efficient and effective as per the quality standards defined for software products. Quality cover letters Quality Manager cover letter example. 2,408 Quality Assurance Manager Medical Device jobs available on Indeed.com. Responsible for training of the Quality Inspectors, GD&T, metrology and establishing company level of inspection acceptance per industry regulation and company procedures. Resume Text. Quality Control/Quality Assurance Manager. Monitoring all inspection and testing equipment to ensure current and valid calibration. Looking to obtain the Quality Assurance Operator position in Nestle. Resume. Nikhil XXXXXXX Mobile No: 9xxxxxxxxx Email Id : nikxxxxxx@yahoo.co.in OBJECTIVE:-A top performing quality assurance manager with a 9 year record of achievement in the IT and Engineering sectors. Implementing the Medical Device GMP Quality System Regulation, STAT-A-MATRIX, 1999 . Senior Software QA Engineer Resume. Build your resume in 15 minutes. Best 22 Quality Control Resume Objective Examples You Can Apply. Summary. Solid Expertise In For Various Testing Telephony Clients And Interfaces (Web Based, Standalone And Voice Activated). Administration of Medical Device market authorizations and country registrations for worldwide distribution. Skilled troubleshooter and Managerial techniques Quality Assurance in Software Testing. Recognized for outstanding ability to embrace change, thrive on challenges, and increase productivity and efficiency. The process is new and evolving and there are many questions both from industry and the Center. 1. Our free quality assurance specialist cover letter templates are a great place to learn about the process. 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 finished product. Quality Assurance Specialist Resume Examples. Experience in electromechanical product development including mechanical, electrical and software design. 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. Deliver quality controls and … Additional Production Resumes are available in our database of 2,000 sample resumes. Optimizes Quality Assurance standards, policy and … Reading blueprints and specifications. Active member of the Guidance and Regulatory Monitoring group, Sterility Assurance Center of Excellence and the Audit Management team ensuring current industry standards, best practices and changing regulations are adequately assessed and applied to business processes. Bachelor of Arts : General Science and Management. Member of the business Quality Assurance management team responsible for creating and supporting a Quality culture across sites by driving compliance activities and integrating QMS accountabilities. Report Job. 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. Liaison with customers and regulatory agencies to obtain audit approvals and accreditations. American Society for Quality Control (ASQC). Overview of the Quality System Regulation for Medical Devices FDA Small Business Regulatory Education for Industry (REdI) Silver Spring, MD September 30, 2015 Tonya A. Wilbon Quality System Specialist Committed to self-education concerning new technologies, with flexibility in adapting to user group needs. Headline : Machine Operator/shipping/and Quality Inspector thorough and detail oriented with experience in the medical device, strong communication skills both verbal and written, on GD&T, OGP vision systems, and ERP Software. training of Regulatory and customer requirements. Leverage industry best practices and improve policies to ensure regulatory compliance and cross-site standardization for Training, Visual Inspection, Concession, Internal Audit, Investigations, CAPA and Document Change Control. Quality Assurance Manager Medical Device jobs. Medical Device quality assurance and regulatory compliance professional possessing over 28 years' experience. Medical Device Quality Assurance Compliance Expert with FDA Employment Experience Technical Consultant #1666 Expertise. 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. Responsible for supplier control in compliance with Medical Device Industry, customer and company specification. Avantec Vascular, Houston, TX . Directed internal sales group, advising on sales strategies and tactics, conducting business trend analysis, and forecasting projected sales. 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 Chose the Best Quality Assurance Resume Format. Try it Free! Quality Assurance (QA) Technician; QA Specialist; Starting Salary: €30,000 to €36,000; After 2 Years: € 36,000 to €45,000; After 5 Years: €45,000 to €50,000; Starting Salary: $38,840; After 2 Years: $48,550; After 5 Years: $58,260; Quality Control Associate. Post Jobs to Multiple Job Boards & Get more Candidates . This includes compliance with legal requirements and standards set by regulatory bodies. The fate of your resume could rest on your Quality Engineer resume objective. Directed customer service sales and marketing for international customers, providing exceptional customer service that met customer needs and international business standards. Responsible for the approval of all Validated Processes; IQ, OQ, PQ, per FDA and Medical Device regulations and customer requirements. Secured and finalized contracts while serving as the new product development engineer. Back to Search Result GO. It is similar to running a quality test, if your statement does not conform to the reader’s standard it will be rejected. External testing group providing quality-assurance assessment of software, hardware and systems. Quality Engineer Resume Objective. Used HP Quality Center for creating and executing test cases, for defect tracking and for generating reports. As such, it is not owned by us, and it is the user who retains ownership over such content. Resume: SAMRADNI RAJARAM PATIL **** ***** ***** *** # *** Mentor, OH 44060440-***-**** Mob: (440) 463 acclbu@r.postjobfree.com. Effectively coached and mentored key individuals ensuring depth of knowledge relevant to quality goals and regulatory compliance. This position will also support device complaint investigation and failure analysis as required. Performed audits to ensure that ISO 13485/FDA 21CFR820 requirements and standards were consistently met. Please provide a type of job or location to search! Quality Auditors, or Certified Quality Auditors, oversee testing to ensure that products meet the established standards of appearance or performance. Professional consulting; FDA Medical Device Quality regulations and FDA compliance. Implemented and coordinated the Supplier Quality program. Experienced quality assurance engineer, quality systems auditor, project manager, usability expert and validation specialist. Midlevel Quality Engineer Resume Sample. Manufacturing, pharmaceutical, biologic, and medical device operations. This activity can be made much easier by utilizing a cover letter for the quality assurance officer template. Preferred minimum 7 years experience in Quality Assurance and or Regulatory Affairs, involving US FDA Class II or Class III medical devices including knowledge & experience of applying global device laws & regulations for adverse event reporting and product recalls Quality Assurance, GS-1910 TS-67 March 1983 TITLES Quality Assurance Specialist is the basic title for all nonsupervisory positions in this series. Developed detailed manufacturing cycle time forecasts and established precise cost estimates for product launches by closely analyzing pricing and market trends. Member of the CAPA Leadership Strategy Team delivering Investigation and CAPA training and qualifying trainers to deliver a consistent approach to documenting and executing in depth investigations, CAPA and action plans. In food companies this position may be combined with VP of Manufacturing or VP of Operations. right; Diligent high school tutor with 3+ years experience editing assignments and preparing teenagers for university. Now that you know how to write a resume for open Quality Assurance positions, write a cover letter that will open doors with help from our Quality Assurance cover letter sample. Quality Assurance Specialists work in the manufacturing or software development industry and are responsible for checking products for defects. > Solid experience in documentation for all aspects of computer system. Contact this candidate. Quality Assurance in Software Testing is defined as a procedure to ensure the quality of software products or services provided to the customers by an organization. Sort by: relevance - date. FDA Regulations, 21CFR820, Aerospace Standards ISO9001/AS9100, and Environmental Resumes, and other information uploaded or provided by the user, are considered User Content governed by our Terms & Conditions. 4 years of experience in Software Test design, Testing and Quality Assurance Management. A team player, able to interact effectively at all levels. Standard ISO 14001. Quality Inspector/Completions Center Resume. Responsible for the approval process. Quality Assurance Specialist Resume Sample Three is one of three resumes for this position that you may review or download. Quality assurance technicians perform various functions in ensuring only top quality products leave their company’s production facilities. Six Sigma Green Belt offering three years of experience in quality engineering, lean manufacturing and product/process design. Career Objective and Career Summary for resume -06/16/14 « Previous ; Next » 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. Best 21 Objectives for Quality Assurance Resume you can quickly apply. Your quality assurance specialist cover letter is your chance to sell the skills, abilities and experience that cannot be fully fleshed out in a resume – the intangible things that set you apart from the competition. aspects of medical device quality and regulatory systems, auditing, project management, design control and development. Developed and implemented the QMS, Quality Policy and Procedures to ISO9001/AS9100 and NADCAP Regulatory requirements. Additional Production Resumes are available in our database of 2,000 sample resumes. 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