Lead Technician Analyst, A+ Certified
2012-01-31 10:19:32
CompuCom is looking for Deskside Technical Support Analysts for onsite installation of a major account. The Technicians will provide installation of hardware and software in a retail store environment. Leveraging best practices, tested technologies and experience, Technicians will ensure high availability, efficiency and security to all access devices. These candidates must be available for shift coverage and staggered start times. Responsibilities: Install, configure and upgrade (IMAC) of Access Devices: Personal Computers, Desktops, blade servers, server racks and POS devices, and related peripherals Support varied Operating Systems including command line scripting Perform back out and recovery duties Perform system image and software by utilizing the customer scripts Verify software images Troubleshoot hardware and software related problems for end users Perform installation break/fix activities providing installation warranty support Resolve problems within a identified service level agreement time frame Provide end-user training on new installations and answer “how-to” questions Maintain hardware sparing inventory requirements Perform installation reporting requirements meeting deadlines Interface with the customers support desk while performing problem resolution Interface with internal and external support desks to obtain technical assistance Provide warranty coordination Determine users? requirements prior to IMAC performance Maintain a high quality, clean job site ... Read more »
Senior Network Engineer - NEEDED NOW!!
2012-01-31 10:19:32
WHY WAIT? Are you looking for an exciting new opportunity? This may be your lucky day! It is time for a change, and CDI can help! We have an immediate need for a Senior Network Engineer JOB DESCRIPTION Our client is looking to hire a PERMANENT Senior Network Engineer. This position includes responsibilities of a senior technical advisor with a focus on supporting systems initiatives on a highly strategic level through analysis of business objectives and technical requirements. The Sr Network Engineer provides leadership integrating new technologies into the network and initiating projects to upgrade the network infrastructure. Additionally the candidate will be responsible for the definition and documentation of standard design models and paradigms to support the enterprise and online service requirements at EP. The Network Engineer will also review emerging network technologies and assess the potential benefit to EP and provide leadership for cross-functional project teams within the Systems and Networking organization. Additional responsibilities include: - Develop and define strategic direction, including the seamless integration of new products into the network - Provide tactical and strategic input on overall network planning and related projects. - Estimate and manage network load and capacity. - Address problems and issues that have major impact on online service or business units. - Install, administer and support various network systems and services (routing, switching, firewalls, intrusion detection, VPN, DNS, SMTP) in a heterogeneous environment, including a highly available Internet service delivery across multiple data centers. - Work with third-party vendors in support of the network infrastructure. Skills: Required qualifications: - Bachelors Degree (Concentration in MIS/Engineering preferred) - Cisco Certified Internetworking Expert (CCIE) certification - 10 years of relevant industry experience working in complex network environments consisting of enterprise and online service offerings. This experience should include - Routing, LAN Switching, Virtual Private Networks, Transport services, Voice over Internet Protocol (VoIP), Network Security, Firewalls, Intrusion Detection and Prevention, Security Parameters, and Business Continuity. - Masters Degree (MBA) preferred. Qualified candidates have very strong oral and written communication skills and are comfortable working with executive-level staff throughout the full life-cycle of network engineering projects. Must have prior experience managing/leading large, complex network engineering projects and associated staff. We are looking for a team player who is equally comfortable in both mentoring and peer-oriented roles. The ideal candidate has a passion for networks and networking solutions that drives consistent high-quality delivery and business interaction. Must be available 24x7 to assist with any critical problem or outage. TAKE ACTION! Why wait another day? It is time to act! Apply NOW and join the CDI Team TODAY!!! ... Read more »
2012-01-31 10:19:32
JOHNJP00002265 Qualified & experienced HVAC Journeyman Mechanic. Must provide own Hand Tools & Personal Protective Equipment (i.e. Hard Hat, Safety Footwear, Work Gloves. Eye Protection and Hearing Protection. JCI will provide all Materials & Equipment on-site. Larry Reardon (New England Operations Mgr.) 978-501-6710 Inspect, test and perform Operations & Maintenance (O&M) preventative maintenance inspections on mechanical, electrical and automatic temperature control equipment utilizing results oriented strategies to ensure continuing operation. Some judgment is necessary to determine when assistance is needed. PRINCIPLE DUTIES: 1. Inspect and diagnose mechanical systems using a variety of tools and instruments. 2. Perform specified preventative maintenance including belt adjustments, oiling, greasing and cleaning of equipment. 3. Perform prescribed non-destructive tests; collect and deliver samples for analysis. 4. Communicate with the owner, or the owner¿s representative, ... Read more »
Microwave Antenna Design Engineer
2012-01-31 10:19:32
Job # 4021-BGrowing manufacturer of high-quality antennas for the commercial microwave market, has an opportunity for a Microwave Antenna Design Engineer. Applicants should have 3 to ten years + of experience with a wide range of Antennas and passive microwave devices from 2 – 80 GHz including transmission lines, patch antenna arrays, reflector antennas, sector antenna arrays and waveguide components. This is a full-time position in a fast-paced, customer focused company. If you enjoy a small company where you are involved and see the results of your work. Benefits including medical, dental, life insurance and a 401K. This is an equal opportunity employerUS Citizenship preferred and, Green card acceptableLocation: Boston, MA ... Read more »
Entry Level Project Scheduler - NEEDED NOW!!
2012-01-31 10:19:32
Entry Level Project Scheduler - NEEDED NOW!! WHY WAIT? Are you looking for an exciting new opportunity? This may be your lucky day! It is time for a change, and CDI can help! We have an immediate need for an Entry Level Project Scheduler JOB DESCRIPTION Job Title: Project Planner/Scheduler - Entry Level Position Type: Contract This position will offer you the ability to attend training for a project scheduling tool and then directly apply your technical skills to meet project team and client needs for creating detailed technical schedules and monitoring project performance. This work will include acting as a planning liaison on a wide range of power plant modifications and upgrades. Using a variety of industry and proprietary software tools that you will learn, and under the direction of the project lead, you will perform the following tasks On an ongoing basis, complete and update detailed project schedules, including activities required for each task with durations/constraints. - Assemble supporting documentation to meet project team and client procurement requests/needs. - Project and update manhour budgets using a work breakdown structure (WBS) account system; report expenditures outside the budget scope. - Monitor and report on cost control performance; continuously update actual expenditures and forecast budget impact. There is the potential for you to travel to client offices for design reviews Qualifications: This position requires a degree from an engineering program with a strong academic background. Minimum of AS degree in industrial engineering, electrical engineering or related field. - Use of MS Excel and/or MS Access in creating detailed, interactive spreadsheets, workbooks, and databases. - A proven ability with creating reports by relating and extracting data from a variety of software platforms. - Excellent written and verbal communication skills, with a proven ability to interact and multitask with project team members, clients, and vendors of varying position levels. Valued but not required skills and experience: - Related engineering internship, co-op, or work experience, which includes project controls, project planning, project scheduling, and earned value performance, preferably within the power industry. - Experience with resource loading schedules. TAKE ACTION! Why wait another day? It is time to act! Apply NOW and join the CDI Team TODAY!!! ... Read more »
2012-01-31 10:19:32
Senior Software Developer - Java/Spring - Facebook We are looking for a senior Engineer for a large community driven website that is VERY profitable. Main job responsibilities are to design, code, test, and deploy new software for our site and and Facebook application. Candidates must be able to work in a highly dynamic, fast paced environment and have fun doing it. Ability to work simultaneously on a variety of projects is a must. We promote an open and highly collaborative environment for brainstorming new ideas and designing software solutions. Education: Bachelors or Masters Degree in Computer Science Requirements - 7+ year experience of professional software development - Start-up Experience - Knowledge of all phases of the software life-cycle. - SQL - A web templating language - JavaScript - HTML - Tomcat - Apache - Spring - Hibernate - Struts 2 - Linux - CVS or Subversion - Eclipse Please. Local Candidates ONLY. We are unable to sponsor or provide relocation at this time. ... Read more »
Software Engineer - NEEDED NOW!!
2012-01-31 10:19:32
WHY WAIT? Are you looking for an exciting new opportunity? This may be your lucky day! It is time for a change, and CDI can help! We have an immediate need for a Software Engineer JOB DESCRIPTION 6-month contract to start Duties & Responsibilities: Develop, deploy, test, and maintain software that controls a large test system. Responsibilities may vary from low level hardware control up through interfaces to external factory automation software. Position requires some travel to customer sites in the US and Southeast Asia. At least 5 and preferably 10 years experience writing software for large systems. Development experience using Visual Studio.NET and C# required. Experience with C++ strongly preferred. Some knowledge of networking and digital hardware is preferred. Experience with Linux is strongly preferred. TAKE ACTION! Why wait another day? It is time to act! Apply NOW and join the CDI Team TODAY!!! ... Read more »
Software Engineer - NEEDED NOW!!
2012-01-31 10:19:32
WHY WAIT? Are you looking for an exciting new opportunity? This may be your lucky day! It is time for a change, and CDI can help! We have an immediate need for a Software Engineer JOB DESCRIPTION 6 month contract to start Software Engineer, responsible for the design, development, performance improvement and testing of the run-time driver and all the software applications for a high-speed test instrument. Main responsibility: Design, develop, and test applications for a high-speed test instrument. Qualifications: 7+ years experience C/C++ design and development expertise required. Object-oriented design and development expertise required. Experience with instrument driver/application development is required. Experience in C#/.NET development is desired. Experience in registered based hardware/software integration. Experience in integrating low-level/embedded software with FPGA code. Experience in functional test development and PCIe and PXIe technologies are pluses. Experience in boundary scan technology is desired. VXI technology is a plus. TAKE ACTION! Why wait another day? It is time to act! Apply NOW and join the CDI Team TODAY!!! ... Read more »
Software Engineer - NEEDED NOW!!
2012-01-31 10:19:32
WHY WAIT? Are you looking for an exciting new opportunity? This may be your lucky day! It is time for a change, and CDI can help! We have an immediate need for a Software Engineer JOB DESCRIPTION Software Engineer Candidate will be responsible for design, implementation, testing and customer support for Instrumentation and Tools related software to drive our Testers. Duties include the design and implementation of new features, using C# C++ and COM/ATL, unit testing and verification of the code. Interaction with hardware engineering and other cross-functional organizations will be common. Qualification: BSCS, BSCE, BSEE or equivalent Desired: 3-7 years experience with general software development experience with commercial applications Project work involving developing software applications that control hardware products Solid grasp of Object-Oriented Design and software data structures, UML is desirable TAKE ACTION! Why wait another day? It is time to act! Apply NOW and join the CDI Team TODAY!!! ... Read more »
Global Compliance Manager I - 40086
2012-01-31 10:19:32
This role is designed to support the Company’s Global Compliance communications priorities including implementation of a relevant communications strategy, content creation, communications programs, initiatives and special projects, such as revision of the company’s Code of Conduct. A major component of the job’s responsibilities is compliance-related communications with the company’s health care providers and BSC employees world-wide. Additional support for internal communications activities and specific functional programs and close collaboration with Global Compliance Training and other Global Compliance functions is required. Key Responsibilities Drive Global Compliance Communications content creation, editing, review and approval process and distribution of communications materials. Create communication pieces based on relevant laws, corporate policies or procedures (communication pieces may involve email campaigns, power point, or online presentations) Responsible for researching subject or issue as it pertains to relevant laws or corporate policies or procedures Ability to consolidate policy-based language into approachable, easy to understand, and bite size pieces of information Identify new communication subjects or issues based on changes in the compliance arena and corporate initiatives Responsible for keeping a log of all requests for training or communication initiatives and update as needed; prioritize the log as new requests are submitted to Global Compliance Draft and review training content for online or in-person training initiatives Serve as liaison to other members of Global Compliance to identify training topics and ensure consistent message is being relayed Create and implement appropriate communications strategies in a variety of mediums including but not limited to print, video, presentation and web. Modify as needed so communications remain stay current and effective. Develop and implement regular functional and Company-wide communications, such as regular newsletters and updates. Update Code of Conduct as needed. Assist in collecting and drafting Board of Directors presentation materials Research, maintain relevant benchmarking data; develop metrics for measurement of communications effectiveness. Collaborate with external vendors as needed. Build Quality into all aspects of work by maintaining compliance to all quality requirements. ... Read more »
Sr QA Compliance Auditor - 39515
2012-01-31 10:19:32
Delivering on the promise of medical innovation begins at Boston Scientific By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce. Purpose/Role Statement In this position, you will be responsible for conducting compliance audits at Boston Scientific facilities located in interesting and exciting locations in the U.S. and throughout the world. You will also plan and conduct requested audits of specific products, processes, or areas with the ability to apply and explain real world application of requirements, regulations and standards. You will be responsible for working with QA management/teams on validation, protocol and process reviews, and implementation of requirements in compliance programs Key Responsibilities Plan and conduct scheduled Corporate quality system audits to assess compliance with FDA, ISO, MDD, CMDR, MHLW, AIMD and internal requirements, encompassing both Medical Device and Pharmaceutical Good Manufacturing Practices. Audit scheduling, investigation and presentation of audit observations, findings and reporting. Confirmation of follow-up actions is also key to this role. Participate in planning, coordination, and implementation of Corporate audit policies with Corporate and divisional leaders. You will receive extensive, up-to-date training in order to review, understand, and implement changes related to ISO, QSR and cGMP requirements. Incorporation of this information into Corporate and divisional programs through document reviews, protocol and validation reviews, and training programs, and participation with Corporate and divisional QA on policy/procedure/guideline development. Working Conditions General office environment, with significant domestic and international travel to other BSC facilities for auditing and or/meetings and conferences. ... Read more »
2012-01-31 10:19:32
We are a small, very successful privately owned start up with great clients position to grow tremendously over the next few years. We have a small team looking for a Director of Infrastucture for our cohesive team and looking for someone who likes new technology and a fast paced environment. They much be familiar with Windows as well but Linux is my main objective here. Here is what I am looking for.......... Director of Enterprise Infrastructure Primary role and responsibilities: - Responsible for the architecture, implementation, monitoring and support of infrastructure including networks, firewalls, load balancers, EMC SANS, Oracle database and Java application servers, virtualization, email, and Windows, LInux and VMWare OS administration. - Stay abreast of new technologies and leads platform architecture strategies for internal, production, and DR environments. - Own enterprise licensing of all software products used to support, develop and implement our solution. - Provide oversight and ensure compliance for infrastructure backup and disaster recovery plan for corporate office and hosted facilities. - Manage the team responsible for the setup, administration, backup and recovery of Oracle production RDBMS Instances · Develop and implement internal IT strategies including outsourcing as well as software and hardware upgrades. - Leads the architecture, implementation and support of collocated hosting facilities. - Partners with technology leadership team to architect high performance high availability environments including implementing a scalable SAN solution and a load-balanced server farm. - Manage the infrastructure budget and hardware procurement - Create and support product development environment and technologies - Supervise system administrators responsible for the internal technical support of hardware and software issues - Process customer database and application upgrades - Provide internal documentation for installing, upgrading and configuring entire product suite - Communicate with clients when needed to expedite the troubleshooting process - Manage the delivery of a 24x7 technical support operation. Skills: - Experience architecting High Availability (HA) production infrastructures - Experience installing, administrating and tuning middle-tier applications, web servers and Oracle databases - Knowledge of scripting languages and technologies to automate maintenance, deployment and monitoring of our enterprise application - Experience capacity planning and hardware sizing for J2EE applications and Oracle databases - Experience managing strategic vendor relationships - Experience implementing network security design and policies - High proficiency with Windows Server 2003, RHEL and Oracle Database Server - Excellent written and verbal communication skills - Excellent professional and teamwork skills - Ability to learn new technologies quickly and understand complex problems - Ability to work directly with external customers to provide support for the technical and database environments - Committment to comprehensive and in-depth analysis, planning, and implementation of every work effort Preferred experience: - Expert knowledge of Microsoft Exchange - Experience with implementing SAN and Load Balancer Solutions - Experience with Tomcat, JBoss, MS SQL Server - Experience with the following helpful: - MDaemon, FTP Serv-U - StarTeam 4.2, Starteam 2005, Mercury Quality Center, Confio Ignite, - Postini, CA Arcserve, - VMWare Server Bachelors Degree in 4 year program (preferably with a concentration in Computer Science or other technical program) · Experience with setup, configuration, and administration of Oracle and other relational databases. · 5+ years as a senior network engineer and experience leading others. ... Read more »
2012-01-31 10:19:32
We are a small company and wildly succesful looking for a hands-on Director of Network and Systems Operations that could lead 3-5 people and outside resources. We are looking for "The Man" This job is running the entire Data Center The Must haves are: Cloud, Co-location, JAVA Stack As Director our Web Operations team, the Web Systems Group provides daily support to our various business departments and works on small- to medium-sized infrastructure projects. Job Requirements : 5+ years experience as a Systems Administrator or Systems Manager in a mixed unix environment at a commercial web publisher. Experience must include Linux, Apache, MySQL and Java based application servers. Proven ability to troubleshoot network and software applications Demonstrated leadership ability Ability to function highly during a crisis including the skills required for communicating effectively during such times. Big Pluses Include: Experience managing a Unix environment that supports an Oracle database Experience managing environments supporting Interwoven Teamsite, Precussion Rythmyx or Drupal content management systems. Advanced scripting capabilities Experience planning or implementing DR, virtualization and cloud environments ... Read more »
2012-01-31 10:19:32
Systems Operations Engineer-UNIX/Linux w/ Perl/Python & SQL, Senior We are a large Successful company located in Cambridge looking for a leader in the System Engineering group we are looking for 5+ years UNIX/Linux Admin that has strong SQL, can Script with Perl or Python creating tools and Automation. Overview:About the Job The job consist of various tasks, from software installs, configuration installs, creating maintaining alerts via SQL, automating tools, to being escalation for the NOCC. The environment is very team orientated and communications skills are much needed in order to support the complexity of the buisness platform Responsibilities:The System Operations group maintains the distribution of software to our global network and as a member of the team you will: * Serve as Tier 3 escalation point for the Network Operations Center in identifying, troubleshooting and resolving network and server issues. * Proactively and reactively develop and document procedures for problem resolution. * Create and maintain tools, alerts and scripts to monitoring and administer the deployed network. * Perform advanced system administration, including phased installs of proprietary software across the deployed network. * Develop and provide training to Operations and Engineering personnel on a variety of operational concepts and procedures. * Serve as liaison to Engineering groups, representing Operations concerns in product development meetings, and facilitate the deployment of internally developed software. * Participate in on-call rotation. Qualifications:Basic Qualifications * Minimum 5 years experience in system administration, network operations, or other related field. * Minimum 5 years experience with operating system concepts. * Minimum 5 years experience with advanced networking and Internet principles, including routing, client/server programming and design of consistent network wide file system layouts. * Minimum 3 years experience with SQL, PERL or Python, UNIX shell scripting in order to support network and provide automation of new and existing tools. Desired Qualifications * Strong interpersonal skills, ability to work with close knit team. * Strong communication and documentation skills. * Ability to triage, prioritize and resolve issues quickly. Other Information * Is relocation available for this position: No * Is US Citizenship required: No * Is a Security Clearance Required: No If yes, applicants selected will be subject to a government security investigation & must meet eligibility requirements for access to classified information. We provid market-leading, cloud-based services for optimizing Web and mobile content and applications, online HD video, and secure e-commerce. Combining highly-distributed, energy-efficient computing with intelligent software, we have grown from a theoretical "big idea" in 1998, into one of the world's most successful technology companies. ... Read more »
Software Engineer - NEEDED NOW!!
2012-01-31 10:19:32
WHY WAIT? Are you looking for an exciting new opportunity? This may be your lucky day! It is time for a change, and CDI can help! We have an immediate need for a Software Engineer JOB DESCRIPTION Software Engineer, responsible for the design, development, performance improvement and testing of the run-time driver and boundary scan software applications for a digital test instrument. Main responsibility: Design, develop, and test boundary scan API and support applications for a digital and a high-speed test instrument. Experience in C#/.NET development is required C/C++ design and development expertise required. Object-oriented design and development expertise required. Experience with instrument driver/application development is desired. Experience in boundary scan technology is desired. TAKE ACTION! Why wait another day? It is time to act! Apply NOW and join the CDI Team TODAY!!! ... Read more »
2012-01-31 10:19:32
Enthusiastic SQL Developer Do you like working on software products? Do you have a passion for technology? Our multi-million dollar client is looking for you . Strong SQL developer with C# and C++ in a Windows environment. Must have 5 plus years of full life cycle development for a commercial product. Are you a visionary? Do you look at a product and say, ?I can make this better!? Then please contact us now so that we can put you in touch with your destiny. DUTIES AND RESPONSIBILITIES: Day to day duties will involve analysis, design and development of current software applications using C# and C++. Must also be able to troubleshoot and correct problems with SQL database and create a technical solution. Last, but not least must thrive on finding new features for current product and have a vision about future products. Technical Qualifications: • Experience developing to relational DBs (e.g. SQL Server Express), SQL queries and stored procedures .Five plus years full life cycle development using C# and C++ Solutions oriented. Understands technology and knows how to design products Also must have the following attributes: • Experience working in cross-functional and geographically distributed teams • Participating in projects from conception to production to maintenance • Knowledge and vision sufficient to help map future product direction • Experience developing Windows based software products • Experience designing and developing software to real-time constraints ... Read more »
Informatica/Siperian Software Engineer
2012-01-31 10:19:32
Company Information: Breakthrough Careers! A career at Millennium: The Takeda Oncology Company comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality. Position Summary: Millennium is seeking a senior level software engineer specializing in Informatica PowerCenter and MDM (aka Siperian) to develop and support our Commercial systems. The Commercial Systems group supports the business activities of Sales, Marketing, Commercial Operations, and Global Medical Affairs. The role's primary objectives include documenting business requirements, designing system integrations (ETL) using Informatica PowerCenter, configuring the Informatica MDM platform, and providing operational support. MDM and ETL needs typically emerge as part of other project initiatives and involve working closely with business users, project managers, application developers, and 3rd party vendors. Excellent communication and collaboration skills are essential. The ideal candidate will be comfortable working in a dynamic business environment and adapting to address emerging business priorities. Duties and Responsibilities: Collect and document business requirements for integration and MDM needs. Design, document, and test integration processes that extract, transform, load, and cleanse Commercial data. Configure and maintain the Informatica MDM Hub to support loading, cleansing, matching, merging, and publication of MDM data. Configure and maintain Informatica Data Director to support management of MDM data by the Data Steward team. Perform operational activities including job monitoring, troubleshooting, data analysis and extraction, and other administrative functions. Collaborate with other team members and groups in IT to ensure high quality solutions are delivered in a timely manner. Follow Millennium's SDLC including documentation of requirements, functional specifications, detailed designs, and test cases. Qualifications: BS or MS in Computer Science or other scientific/engineering discipline with at least 4 years of relevant experience. Demonstrated experience and proven technical proficiency in the development of ETL mappings/workflow using Informatica PowerCenter. Demonstrated experience and proven technical proficiency in Informatica MDM. Experience using Oracle RDMS (10.2 or higher) with strong SQL and PL/SQL programming skills. Excellent interpersonal and communication skills: oral and written communication, ability to work collaboratively, and comfortable working in a dynamic, cross-functional environment. Experience in a biotech or pharmaceutical organization, especially in Commercial, is preferred. Want to learn more about us? ... Read more »
2012-01-31 10:19:32
Summary:Sustain product complaint activities for the Endosurgery Complaint Management Center (CMC). - Ensure complaint handling tasks are completed as required in compliance with company policies and procedures and applicable industry regulations (e.g. FDA 21 CFR Part 820.198, FDA 21 CFR Part 803, ISO 13, etc. - Manage product complaint volumes and/or complexities commensurate for a Product Analyst I. - Help identify possible CMC workstream improvements directed to increase the effectiveness, integrity, and/or timely management of complaint files. - Assist Senior and/or Principal level Analysts to implement complaint handling process improvements, as required. Responsibilities: - MDR assessments for all assigned products - MDR assessments for all assigned products. - Prepare and submit FDA MedWatch within the mandated timelines. - Accountable for managing thorough and accurate complaint records, as well as timely closure of complaint files. - Ensure complaint records, MedWatch reports (FDA Form 3500A), and applicable complaint handling documents are compliant with Good Documentation Practices (GDP). - Complete mandatory training by established due dates. - Partner with Complaint Investigation Sites (CIS) to ensure thorough and timely investigation reports. - Professional contact with customers to gain insight into each complaint event. ... Read more »
2012-01-31 10:19:32
Purpose/Role Statement Assists the Manager, Clinical QA, with internal quality assurance program for the assigned business area.Serves as clinical QA representative on clinical project teams and conducts internal and external quality audits to assure that BSC clinical investigations comply with all applicable regulatory requirements and BSC policies and procedures. Key Responsibilities · Participates on clinical project teams. · Plans, schedules, and conducts internal and external quality assurance audits of the systems, procedures, and controls employed in the design, conduct, and analysis of clinical trials. · Assesses sponsor/investigator/monitor compliance with protocol and GCP/ICH requirements. · Assesses the accuracy, validity, and quality of the scientific data generated during clinical trials. · Documents audit observations; evaluates impact, and makes recommendations for corrective actions. · Communicates observations to clinical investigators, clinical program managers, directors, and management. · Evaluates responses to audit findings and ensures that appropriate corrective actions are completed. · Keeps abreast of current worldwide regulatory requirements. · Supports departmental, functional, divisional, and corporate quality goals and priorities. · Updates the audit database. · Assists with preparation of, coordination, and management of regulatory agency inspections of BSC offices. · Assists with preparation of investigator sites for FDA or other regulatory agency inspection. Quality Systems Duties and Responsibilities · Performs vendor assessment audits prior to contract initiation. · Reviews essential documents such as protocols, CRFs, and informed consent forms for adequacy and compliance with GCP and regulations. · Audits investigator sites for compliance with regulatory and SOP requirements. · Builds quality into all aspects of work by maintaining compliance to all quality requirements. ... Read more »
2012-01-31 10:19:32
The CIS Quality Engineer I is an active participant within the Business Unit Complaint Investigation Site (CIS).This role is responsible for managing the customer complaint failure analysis process for assigned product families; coordinating investigations with the External Manufacturer (EM); monitoring trending of product performance data and providing interpretive summaries of results; ensuring compliance with policy, procedures, and regulations applicable to Post Market Surveillance EM complaint handling, and working with EM partners to manage CAPA issues associated with external complaints. Responsibilities: -Sustain product complaint investigation activities for the Endosurgery EM Complaint Investigation Site (CIS) - Interface with intra and inter site personnel to facilitate timely analysis of customer return product classified as a complaint -Become proficient in the use and maintenance of applicable equipment and/or tools -Manage failure investigations including root cause determinations and documentation of findings -Interpret and evaluate the product analysis, and recommend the need for additional actions including initiating CAPA’s and working with EM partners to drive their closure. -Works closely with EM quality assurance personnel on performing product evaluation, final analysis, reporting of such analysis and CAPA’s -Assist EM partners to conduct on-site failure investigations and visits as required - Accountable for managing thorough and accurate complaint investigation records, as well as timely closure of complaint investigations - Develop protocols/plans/procedures/requirements for testing of returned customer complaint units in support of company’s quality program -Apply existing techniques and procedures with recommendations and implementation of modification for improved efficiency or develop new analytical methods and techniques -Promote Good Laboratory Practices and comply with site safety and health hazard requirements when working in the lab and when working with lab personnel -Works cross-functionally (EM’s, engineering, clinical/medical) in identifying and resolving issues -Work w/ BU Compliance and EM QA personnel in support of various quality systems including but not exclusive to: * Management controls * Corrective and Preventive Actions (CAPA) * Supplier management * Training ... Read more »