*Position: Quality Engineer* *Location: Carlsbad,CA* *Duration: 6+ Months* *PHONE AND SKYPE*
*NEED A CANDIDATE WITH recent medical device work experience* *ESSENTIAL DUTIES AND RESPONSIBILITIES:* · Design, create, verify/validate routine and adhoc reports regarding various aspects of complaint activities to a multitude of different departments located in different locations. · Designing and maintaining SharePoint sites that are related to Post Market Vigilance (PMV) Activities. Information loaded to the site is used by the department as reference material, so up-to- date data is essential. · Build and maintain Access databases used for monthly and adhoc reporting · Develop and maintain tools for use by business operations where they can pull data on demand and tools to assist in their analysis of business operations · Suggest and implement system improvements based on user requests · Provide training and administer the Complaint Tracking System (CTS) or other tools developed within the team · Generate T-SQL and Access queries, charts and perform analysis of complaint data in support of · Monthly metrics · Corporate metrics · Product Quality Improvement Teams · Provide technical support to projects related to CTS, as required. · Support MITG-wide PMV Analytics improvement projects, as required. · Generate/develop trend reports · Participate in process improvement projects such as: · Complaint tracking system improvements · Provide backup support for other CTS administrators. · Provide backup support for the corporate monthly metric report · Assist with various Analytic projects (i.e. data mapping, validation, database table assessments, etc). Required · Education: Associate Degree or 3+ years of experience in a similar role · Data management: 2+ years in a data management, statistical, and/or analytical role in medical devices, pharmaceuticals, biotechnology or healthcare. Candidates with data management, statistical and/or analytical experience from other industries will be considered · Project Management: Small scale project management · D/B Management: Familiar with T-SQL, Access, Business Objects · BI Tools: Familiar with BI software/tools such as Tableau, TIBCO SpotFire, SAS · Query Writing: Advanced level building queries in Access, SQL or in similar languages tools · Excel Experience: Solid background with standard formula building, nested IF statements, standard calculations, Vlookup, Hlookup, charting/graphing, pivot tables and can build advanced formulas (macro knowledge is a plus) · System Validation: 2+ years’ experience validating systems, writing test protocols preferably in a regulated industry such as biotechnology or healthcare · SharePoint: Working knowledge of SharePoint sites and is able to build SharePoint sites for collaboration and documentation purposes. InfoPath experience a plus. · Proficiency in Word, PowerPoint, Visio · Have the ability to write work instructions in an easy to understand manner for the non- technical audience. · Demonstrated ability to communicate clearly both verbally and in writing · Must be a team player – willing to work with other departments and divisions · Excellent documentation and communication skills. · Attention to detail and a commitment to quality work · Detail oriented and highly organized · Excellent customer service skills · Requires some direction but then is able to work with minimal supervision on repeated/similar tasks Preferred · Programming experience a plus · Knowledge of quality control concepts a plus · Knowledge of the FDA Quality System Regulations and ISO Quality System Standards a plus · Post-Market Vigilance/Surveillance and/or Patient Safety/Risk Management experience a plus. -- *--Thanks & Regards,Vikas Kumar Singh* *Okaya InfocomEmail: vikas.si...@okayainc.com <vikas.si...@okayainc.com>* -- You received this message because you are subscribed to the Google Groups "US_IT.Groups" group. To unsubscribe from this group and stop receiving emails from it, send an email to us_itgroups+unsubscr...@googlegroups.com. To post to this group, send email to us_itgroups@googlegroups.com. Visit this group at https://groups.google.com/group/us_itgroups. For more options, visit https://groups.google.com/d/optout.
