Quality Assurance Engineer Jobs in Rhode Island

Job Title: Quality Assurance Engineer Job Company: Fidelity Location: Smithfield, RI Description: Quality Assurance Engineer Job Quality Assurance Engineer - 1000245DescriptionPosition DescriptionFidelity Investments Institutional Services (FIIS) Customer Data Information Systems (CDIS) team is responsible for designing, building and maintaining the FIIS sales and marketing management information systems including infrastructure support for Informatica and a large Oracle data warehouse. The CDIS team seeks a strong QA Engineer to work on large and small technology and business projects through successful completion.As a member of the FIIS Customer Data Information System (CDIS) Team, you will work with business and systems teams to define, documents and execute test plans to ensure new applications and enhancements to existing applications satisfy business requirements.Primary Responsibilities* Assures project meets quality standard* Work under moderate to minimal direction* Works with on-site and offshore technical leads* Creates test plans, data, procedures and manual and /or automated scripts* Writes complete and accurate software defect reports* Coordinates test Schedule:s and manages progress of all test activities against plan* Establishes testing entrance and exit criteria, working with the project team* Identifies and manages critical path of testing* Ensures execution of project regression test tasks* Analyzes and reports overall test status and results* Defines regression tests for future projects* Works on moderate to complex assignments* Identifies and resolves technical issues* Provides technical supervision on small to moderate projects* Has input into departmental policies and procedures.* On occasion, addresses small groups on technical subjects or demonstrates systems* Build and strengthen relationships within and external to CDISQualificationsEducation and Experience* College degree: B.S. in a computer-related field is preferred, B.A. (with applicable experience) may be acceptable* 4 - 5+ years of solid software testing background through extended quality assurance experience* Full project life cycle experience* Application/technology knowledge in several areas including Oracle, Informatica, SQL, batch processingSkills and Knowledge* Solid understanding of the software development process including analysis, design, coding, system and user testing, problem resolution and planning.* Ability to multi-task, manage time and priorities, and meet scheduled deadlines* Strong written and verbal communications skills* Team player with a talent for problem solving and troubleshooting* High level of attention to detail* Basic knowledge of database querying and ability to navigate Unix environment* Projects may require integration, with impact to one or more business practices, and technology platforms.Company OverviewFidelity Investments is one of the world's largest providers of financial services. Fidelity offers investment management, retirement planning, brokerage, and human resources and benefits outsourcing services to over 20 million individuals and institutions as well as thousands of financial intermediary firms. The firm is the largest mutual fund company in the United States, the No. 1 provider of workplace retirement savings plans, the largest mutual fund supermarket, a leading online brokerage firm and one of the largest providers of custody and clearing services to financial professionals. For more information about Fidelity Investments, visit www.fidelity.com.Job: QA/TestPrimary Location: RI-SmithfieldSchedule: Full-timeJob Level:: Individual ContributorEducation Level: Bachelor's Degree (16 years)Job Type: StandardShift:: Day JobOvertime Status:: ExemptTravel:: No

Job Title: Quality Engineer Company: Concordia Medical LLC Location: Warwick, RI Description: Concordia Medical, a manufacturer of absorbable medical device textiles, seeks an experienced quality engineer from the medical device industry.   The ideal candidate will have 5-7 years experience working in the medical device or pharmaceutical industry familiar with FDA and ISO 13485 regulations.   Duties include:   Manages the Company's Quality System to maintain certification to ISO13485 and ISO9001 standards, and keeps informed about industry trends and requirements of FDA's QSR. Responsible for administration of NCM, CAPA, and Customer Complaint Systems and compliance with documented procedures. Responsible for developing Internal Audit schedule, training of auditors, and assuring timely completion of audits. Manages Document Control Center and Quality Assurance Lab. Manages internal and external monitoring and compliance with proper operating conditions of Medical Controlled Environment Space areas. Develops and initiates standards and methods for inspection, testing, and evaluation. Establishes program to evaluate precision and accuracy of production equipment and testing, measurement, and analytical equipment and facilities. Interacts with customers, vendors and other employees concerning problems with quality and assures that effective corrective action is implemented. Manages supply chain certification and ongoing monitoring of supplier performance. Schedules Management Reviews as required and reports to management on quality issues, trends and losses on an ongoing basis. Ensures that proper inspections have been performed to ensure product quality.  This will include the inspection of incoming material as well as in process and final inspection of finished product. Designs, documents and implements methods for process control, process improvement, testing and inspection. Responsible for leading company's Risk Management compliance.     Qualified candidates must have: - BS in Engineering, Quality or related field- 5-7 years working in the medical device industry in the Quality function.- Thorough working knowledge of Quality systems- Demonstrated ability to develop and implement Quality systems through the supply chain- Demonstrated ability to lead and develop a Quality organization- Working knowledge of manufacturing processes.- ASQ or similar certification

Job Title: Senior Advanced Quality Engineer - Tissue Regeneration Products Company: C. R. Bard, Inc Location: Warwick, RI Description: Overview: Sr. Quality Assurance Engineer - Tissue Regeneration Products Davol Inc. Warwick, RI Summary of Position with General Responsibilities: The candidate shall participate in cross functional teams to ensure the effective implementation of design controls in support of the development and launch of Allograft, Xenograft, and AB coated tissue regeneration products. This candidate shall have proven leadership skills, and demonstrated ability in risk based decision making and problem solving. This position reports to the Senior Advanced Quality Engineer/Supervisor and is responsible for assuring that new product designs and processes meet all Corporate and Divisional requirements with respect to safety and efficacy. Essential Job Functions: Support design control activities for new product development process and regulatory submissions.  Provide technical guidance to Quality Engineers, Quality Technicians, and Inspectors.Lead Quality Engineering Projects to improve Davol Systems and Procedures.Perform product and process risk assessment activities, including Hazards Analysis, and Lead Design/Process Failure Modes & Effects Analysis (DFMEA/PFMEA).Conduct and lead design verification/validation and process validation activities.  Provide Quality Engineering leadership for analytical test methods and stability testing in order to ensure compliance with ICH guidelines, ISO-13485, 21CFR 820, 210, 211, 1270, 1271 and/or requirements as applicable.  Develop biocompatibility test plans in compliance with ISO-10993 and Corporate guidelines.  Co-ordinate the testing at outside laboratories and document results.Develop, document, and validate Inspection and Test Methods to support design control, in-process inspection, and final inspection activities.Develop shelf life and stability test protocols for combination devices with Active Pharmaceutical Ingredients (API’s).  Develop manufacturing control plans for internal and outsourced processesSupport Corrective and Preventive Action Process for product/process non-conformances, customer complaints, and internal audits.Support Product/Process Transfers from Pilot facilities to Manufacturing Facilities.Support design control activities for new product development process and regulatory submissions.  Provide technical guidance to Quality Engineers, Quality Technicians, and Inspectors.Lead Quality Engineering Projects to improve Davol Systems and Procedures.Perform product and process risk assessment activities, including Hazards Analysis, and Lead Design/Process Failure Modes & Effects Analysis (DFMEA/PFMEA).Conduct and lead design verification/validation and process validation activities.  Provide Quality Engineering leadership for analytical test methods and stability testing in order to ensure compliance with ICH guidelines, ISO-13485, 21CFR 820, 210, 211, 1270, 1271 and/or requirements as applicable.  Develop biocompatibility test plans in compliance with ISO-10993 and Corporate guidelines.  Co-ordinate the testing at outside laboratories and document results.Develop manufacturing control plans for internal and outsourced processesSupport Corrective and Preventive Action Process for product/process non-conformances, customer complaints, and internal audits.Support Product/Process Transfers from Pilot facilities to Manufacturing Facilities.Perform additional duties as assigned.Develop, document, and validate Inspection and Test Methods to support design control, in-process inspection, and final inspection activities.Develop shelf life and stability test protocols for combination devices with Active Pharmaceutical Ingredients (API’s).  Basic Qualifications: ·Bachelor’s Degree in Engineering or Technical Sciences. ·5 years minimum experience in Quality, Manufacturing, or R&D engineering including design controls, product/process validation and technical problem solving in the medical products industry. ·A high level of competence in Quality Technology including statistical techniques, control charts, sampling plans, quality costs, design of experiments, correlation and regression, analysis of variance, and probability. ·Knowledge of FDA QSR’s, cGMP’s’ and/or cGTP and ISO regulations. ·Knowledge of Xenograft, Allograft, and/or combination products utilizing absorbable polymers and active pharmaceutical ingredients is a plus. ·Occasional travel (10%) Additional Desirable Qualifications Skills and Knowledge: Knowledge and Application of Six Sigma/Process Excellence Tools.  Green Belt/Black Belt Certification a plus.Good oral and written communication skills.Demonstrated leadership skills. Ability to work with and motivate people.

Job Title: Principal Quality Engineer Company: Amgen Location: West Greenwich, RI Description: Provide statistical and process improvement expertise to manufacturing site customers to solve complex business problems With minimal direction complete analyses and drive the use of best QE practices to evaluate Quality Systems and Product and Process data The result will be data-driven decisions associated with Quality Operations Senior Management Reviews and Process and Product Reviews Partner with Site Leadership teams Quality Network Owners Quality and Operations Functional Areas and Operations IS to enhance overall Quality System Data Integrity Management and Analysis Statistical tools will be applied to define andor improve variability of key and critical quality parameters Process understanding will include troubleshooting issues observed Apply statistical tools and QE methodologies to optimize existing manufacturing and Quality processes and apply advanced system methodologies to engineer processes when gaps are discoveredEnsures both strategic and tactical direction for Quality Engineering in line with Site and Corporate vision and approachEnsures the Quality Engineering body of knowledge is adequately applied to optimize site quality manufacturing and business processesResponsible for building strong working relationship with other functional leads eg Manufacturing Quality Control QA Supply Chain Process Development to ensure appropriate understanding of business needs and collaborative support-Bachelors degree in Engineering Mathematics or Science -10 years experience applying statistical analysis andor process improvement methodologies to drive process improvement and to solve complex business problems -Experience working in a manufacturing environment Preferred Qualifications: -Master's degree in Operations Research/Industrial Engineering, Statistics, Mathematics, Biology, Chemistry, Engineering or Biomedical. -Demonstrated understanding of modern quality tools and management concepts (statistical tools, supplier quality management, statistically designed experiments, acceptance sampling, quality system function and design, etc.). -American Society for Quality (ASQ) Certified Quality Engineer (CQE) -Experience in developing and presenting training material in statistical analysis and/or quality principles to adult learners. If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id Register to View -8972

Job Title: Sr. Advanced Quality Engineer Company: C. R. Bard, Inc Location: Cranston, RI Description: Overview: Senior Advanced Quality Engineer Davol Inc. Warwick, Rhode Island Summary of Position with General Responsibilities: The position of Senior Advanced Quality Engineer is responsible for assuring that existing product designs and processes meet all corporate and divisional requirements with respect to safety and efficacy. This candidate will represent the quality function on cross functional teams to ensure the effective implementation of design controls in support on-going operations and manufacturing. In addition, the individual shall provide secondary support to new product development and acquisition projects as required. This candidate shall have proven leadership skills, and demonstrated ability in risk based decision making and problem solving. This position reports to the Manager of Advanced Quality Engineering. Essential Job Functions:  Provide Quality Engineering support for on-going manufacturing and operations activities. Support new product development and acquisition projects as required. Provide technical guidance to Quality Engineers, Quality Technicians, and Inspectors.Lead Quality Engineering Projects to improve Davol Systems and Procedures.Perform product and process risk assessment activities, including Hazards Analysis, and Design/Process Failure Modes & Effects Analysis (DFMEA/PFMEA).Support design validation and process validation activities. Provide Quality Engineering Support to outsourced analytical laboratories and manufacturing facilities to ensure compliance with 21CFR 820, 210, 211; cGMP's, and ISO-13485 requirements. Develop biocompatibility test plans in compliance with ISO-10993 and Corporate guidelines. Co-ordinate the testing at outside laboratories and document results.Develop, document, and validate inspection and test methods to support design control, in-process inspection, and final inspection activities.Develop shelf life and stability protocols for devices.Develop test protocols and reports to support Regulatory submissions.Develop manufacturing control plans for internal and outsourced processesSupport Corrective and Preventive Action Process for product/process non-conformances, customer complaints, and internal audits.Support Product/Process Transfers from Pilot facilities to Manufacturing Facilities. Basic Qualifications: ·Bachelor’s Degree in Engineering or Technical Sciences. ·5 years minimum experience in Quality, Manufacturing, or R&D engineering including design controls or product/process validation and technical problem solving, in the medical device or biotech industries. ·Knowledge of FDA QSR’s, ISO13485:2003, and ISO 9001:2000. ·Good oral and written communication skills. ·Demonstrated leadership skills ·Ability to work with and motivate people Additional Desirable Qualifications Skills and Knowledge:  A high level of competence in Quality Technology including statistical techniques, control charts, sampling plans, quality costs, design of experiments, correlation and regression, analysis of variance, probability etc.Knowledge and application of Six Sigma/Process Excellence Tools.  Green Belt/Black Belt Certification a plus.