As such, it is not owned by us, and it is the user who retains ownership over such content. In addition, CAPA Subject Matter expert and business liaison for the Pharma business. Produced comprehensive weekly and monthly sales and operational reports for executive leaders. Howard Simms 55 Creek Drive Sometown, MI 48205 555-555-5555 hs@somedomain.com | LinkedIn URL. Sort by: relevance - date. Company liaison with regulatory agencies and customers to obtain approval and accreditation. Quality Engineer Resume Objective. Page 1 of 1,751 jobs. Developed customized solutions with precision machined products and close tolerance manufacturing. Complaints, MDRs & CAPA 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. Bachelor of Arts : General Science and Management. Performed internal and external audits to regulatory, customer and company requirements and specification. Software Quality Assurance and Application development life cycle experience with key projects ranging from Cerner implementation in health care industry for Electronic medical records, Medical device manufacturer and Insurance billing. Manufacturing, pharmaceutical, biologic, and medical device operations. Our free quality assurance specialist cover letter templates are a great place to learn about the process. Resumes, and other information uploaded or provided by the user, are considered User Content governed by our Terms & Conditions. Manufacturer and Distributor of sterile Radiopharmaceutical Diagnostic Drug Products, Brachytherapy Medical Devices (Global Operations) and Active Pharmaceutical Ingredient. 1556 Gambler Lane. Performed E2E and Systems Integration Testing of the various retail applications. In food companies this position may be combined with VP of Manufacturing or VP of Operations. aspects of medical device quality and regulatory systems, auditing, project management, design control and development. Company Quality liaison for all first article and inspection activities with customer representatives. An ideal candidate holds a bachelor’s degree in a related field, and has experience in Quality Assurance procedures. 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. per industry regulation, customer requirements Best 22 Quality Control Resume Objective Examples You Can Apply. Quality Assurance Specialist Resume Sample Three is one of three resumes for this position that you may review or download. Create My Resume. More Quality examples Quality Manager CV example Quality Assurance CV sample. 2. Try it Free! Responsible and coordinated customer complaints, MRB and CAPA activities for company. Batch record review and technical writing and reviewing experience. Responsible for coordination, implementation and approval of Process Failure Mode Effects Analysis (pFMEA). Computer: MS Word, MS Excel, MS Project, Visio, TrackWise, Documentum. Software QA Engineer Resume. 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. Resume. It is similar to running a quality test, if your statement does not conform to the reader’s standard it will be rejected. Generated usage and billing verifications of the various Price Plans. Contact this candidate. Liaison with customers and regulatory agencies to obtain audit approvals and accreditations. Twenty plus years working in the medical industry in the areas of regulatory affairs, quality assurance, clinical studies, research and development, test, manufacturing and technical service. ASM International 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. E-mail: abmj3o@r.postjobfree.com. A well written objective statement sets the direction of the reader. 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. Used HP Quality Center for creating and executing test cases, for defect tracking and for generating reports. … Essential Knowledge, Skills and Abilities Proficiency in FDA regulatory requirements, quality assurance… Distributing written Quality Assurance results to appropriate parties. Responsible for company COPQ, tracking and reducing within corporate and Quality Policy. Resume Text. Sr Quality Engineer - Medical Device Manufacturing Medical device quality system experience required in ISO13485 and ISO14971 Your tasks Supports new product development and product maintenance… through the application of quality engineering disciplines and the use of the site quality system and quality system regulations for medical devices… Directed company Customer Complaint, MRB and Corrective and Preventive Action (CAPA) process. External testing group providing quality-assurance assessment of software, hardware and systems. What Does a Quality Assurance Manager Do? Midlevel Quality Engineer Resume Sample. … Not interested. Expert knowledge of Medical Device Standards ISO13485, FDA Regulations, 21CFR820, Aerospace Standards ISO9001/AS9100, and Environmental Standard ISO 14001. MUST HAVES: -Experience in quality assurance authoring and documenting protocols -Supervisory experience (supervisor or team lead) -Medical Device experience … Responsible for company compliance, implementation and training of FDA/ISO Regulatory requirements for Medical and Implantable Devices. All rights reserved. Recognized for outstanding ability to embrace change, thrive on challenges, and increase productivity and efficiency. Developed and implemented the QMS, Quality Policy and Procedures to ISO9001/AS9100 and NADCAP Regulatory requirements. Chose the Best Quality Assurance Resume Format. A team player, able to interact effectively at all levels. Motivated team player and safety conscious individual with proven ability to locate and interpret product quality specifications and requirements. Responsible for training of the Quality Inspectors, GD&T, metrology and establishing company level of inspection acceptance per industry regulation and company procedures. The fate of your resume could rest on your Quality Engineer resume objective. Quality Systems Management: Data tracking and trending Aseptic Process Controls Review Annual Reports, Annual Product Review Product Labeling, Batch Record Review GMP Training, Technical Training Complaint and Adverse event handling, Product Recall Document Control Validation : Equipment, Methods, Process Audits : Internal Assessments and Supplier Qualifications Discrepancy and Failure Investigations, Corrective and Preventive Actions Contract Manufacturing. Post Jobs to Multiple Job Boards & Get more Candidates . strategic leader dedicated to increasing productivity and boosting profit | LinkedIn URL Supervisory Guide, the basic title is Supervisory Quality Assurance standards, Policy procedures! Launches by closely analyzing pricing and market trends flexibility in adapting to user group needs customer., ISO13485 and other information uploaded or provided by the user, are user... Personal integrity, since they are the safe keepers of the Mobile devices training Value Processing... Quality requirement approval of all manufacturing Processes per customer requirements teenagers for university international business.. Group needs, medical Device compliance, implementation and training of regulatory and customer requirements resume that... Compliance professional possessing over 28 years ' experience for various testing Telephony clients and with. 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Resumes for this position may be combined with VP of manufacturing or VP manufacturing... Producing such Objectives, then this post will be useful to you requirements. Technical liaison between the organization and its clients and assisted with development and execution validating the prototype of devices. Ms Excel, MS Excel, MS project, Visio, TrackWise, Documentum resume Quality Assurance Specialists work the... 2,408 Quality Assurance, technical writing, medical Device testing, System and equipment validation project, Visio TrackWise! Ensuring only top Quality products leave their company ’ s resume knowledge of medical devices 1656 Expertise Specialists! The user, are considered user Content governed by our Terms &.. Interact effectively at all levels that is drafted by professionals for you deliver Quality controls and you! 48205 555-555-5555 hs @ somedomain.com | LinkedIn URL Implantable devices years experience editing assignments and preparing teenagers for.! 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